Product code CCQ
- Device name
- Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5640
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972397 | EZ SPRAY | Intertex Research, Inc. | 1997-09-23 |
| K964956 | E-Z SPACER MASK (SMALL) | Airpharma, LLC | 1997-04-23 |
| K961894 | MDI TUTOR | Mdi Tutor, Inc. | 1996-08-14 |
| K961455 | MEDSHIELD/AEROCHAMBER | Diemolding Corp. | 1996-07-25 |
| K960593 | SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100 | Aradigm Corp. | 1996-05-10 |
| K922033 | SALINE SOLUTION- STERILE | Trinity Laboratories, Inc. | 1992-07-21 |
| K900576 | MODIFIED AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1991-05-13 |
| K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER | Monaghan Medical Corp. | 1991-04-10 |
| K895115 | FRANK INHALER THERMAL S | Buttner-Frank GmbH | 1990-05-18 |
| K894215 | EVOLUTION ULTRASONIC | Medical Industries America, Inc. | 1990-04-16 |
| K894555 | PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED | Dura Pharmaceuticals, Inc. | 1990-01-24 |
| K896070 | PFEIFFER METERED DOSAGE SYSTEM | Syva Co. | 1990-01-17 |
| K895592 | FREEWAY NEBULIZER COMPRESSOR | Lifecare Services, Inc. | 1989-11-21 |
| K894441 | DEVILBISS MODEL 6610D | Devilbiss Health Care, Inc. | 1989-10-13 |
| K894244 | DEVILBISS MODEL 8500D AND 8500D-608 | Devilbiss Health Care, Inc. | 1989-10-06 |
| K892117 | GENTLEHALER(R) | Schering Research | 1989-06-23 |
| K875024 | DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP | Dey Laboratories, Inc. | 1988-01-22 |
| K875011 | DEY-PAK PURIFIED WATER, USP, STERILE | Dey Laboratories, Inc. | 1988-01-22 |
| K874513 | MONAGHAN AEROCHAMBER WITH MASK | Monaghan Medical Corp. | 1987-12-30 |
| K873793 | INSPIREASE(R), DRUG DELIVERY SYSTEM | Key Pharmaceuticals, Inc. | 1987-10-13 |
| K873477 | INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN) | Vortran Medical Technology 1, Inc. | 1987-10-09 |
| K872315 | MISTMASTER | Sonora Respiratory Products, Inc. | 1987-09-11 |
| K871151 | THE SPIRA ELEKTRO 2 | Warren E. Collins, Inc. | 1987-05-15 |
| K870332 | PREFILLED RESPIRATORY THERAPY VIALS | Automatic Liquid Packaging, Inc. | 1987-04-01 |
| K870755 | CHALLENGER DOSIMETER | Salter Labs | 1987-03-16 |
| K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | Salter Labs | 1987-03-16 |
| K860800 | ROSENTHAL-FRENCH NEBULIZATION DOSIMETER | Laboratory For Applied Immunology, Inc. | 1986-03-27 |
| K860875 | CIRRUS DRUG NEBULIZER MK III | Dhd Medical Products Div. Diemolding Corp. | 1986-03-20 |
| K854952 | CIRRUS NEBULIZER-DELUXE KIT | Dhd Medical Products Div. Diemolding Corp. | 1986-01-28 |
| K854551 | MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S | Medipart Jerry Alexander | 1985-12-19 |
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| 10850049784679 | SURGYCO | Surgyco LLC | 2023-10-31 |
| 14026704709899 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 14026704709851 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
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| 14026704709837 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 14026704709820 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 14026704709813 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2023-08-31 |
| 10840330700495 | Procure | Twin Med, LLC | 2022-11-03 |
| 10840330700501 | Procure | Twin Med, LLC | 2022-11-03 |
| 14026704717474 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2020-07-30 |
| 10190752145061 | AirLife™ | AIRLIFE | 2019-12-20 |
| 10190752131910 | AirLife™ | AIRLIFE | 2019-12-20 |
| 14026704670984 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-12-10 |
| 14026704670830 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-12-10 |
| 14026704661463 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-06-07 |
| 14026704645852 | HUDSON RCI | TELEFLEX INCORPORATED | 2019-01-18 |
| 14026704613165 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2018-09-15 |
| 14026704613172 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2018-09-15 |
| 14026704626547 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2018-02-15 |
| 14026704626554 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2018-02-15 |
| 14026704613202 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-10-27 |
| 14026704613141 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-13 |
| 14026704613134 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-13 |
| 14026704613127 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-13 |
| 14026704613110 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-13 |
| 14026704612816 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-13 |
| 14026704613103 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-09-11 |
| 14026704612823 | LMA ATOMIZATION | TELEFLEX INCORPORATED | 2017-05-10 |