Product code BYD
- Device name
- Condenser, Heat And Moisture (Artificial Nose)
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5375
- 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 |
|---|---|---|---|
| K955008 | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | 1996-01-30 |
| K954194 | DISPOSABLE HME/FILTER | Engstrom Medical | 1995-10-20 |
| K953580 | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | 1995-09-15 |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | 1995-09-07 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | 1995-08-25 |
| K953540 | EEE | Edentec Corp. | 1995-08-25 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | 1995-08-25 |
| K953619 | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | 1995-07-25 |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | 1995-07-20 |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | 1995-07-20 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Icor AB | 1995-07-13 |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | 1995-06-12 |
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | 1995-06-08 |
| K952036 | FLEXLIFE | Mallinckrodt Medical | 1995-06-08 |
| K951856 | HUMID-VENT MICRO | Gibeck, Inc. | 1995-06-07 |
| K945359 | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | Artema Medical AB | 1995-02-21 |
| K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | Vital Signs, Inc. | 1995-02-21 |
| K945657 | DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER | Tec II Medical, Inc. | 1994-12-07 |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | Medicomp, Inc. | 1994-10-14 |
| K944194 | DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME | Med-Tek Innovations, Inc. | 1994-09-13 |
| K942794 | HYGROLIFE | Mallinckrodt Medical | 1994-08-22 |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | Icor AB | 1994-08-15 |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | Icor AB | 1994-06-08 |
| K941813 | VENSHIELD | Cybermedic, Inc. | 1994-05-03 |
| K941585 | HYGROSTER | Mallinckrodt Medical | 1994-04-19 |
| K941535 | TRACHEOLIFE | Mallinckrodt Medical | 1994-04-15 |
| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | Intertech Resources, Inc. | 1994-01-25 |
| K934441 | KING SYSTEMS HME | King Systems Corp. | 1993-12-02 |
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| 07331791015564 | Provox Life Coming Home USA | Atos Medical AB | 2022-11-29 |
| 00840117305533 | Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy | Dynarex Corporation | 2022-05-10 |
| 00840117305519 | Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy | Dynarex Corporation | 2022-05-10 |
| 00840117318113 | Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy | Dynarex Corporation | 2021-04-22 |
| 00840117318137 | Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy | Dynarex Corporation | 2021-04-22 |
| 00840117305885 | Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port | Dynarex Corporation | 2021-04-22 |
| 00840117305557 | Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy | Dynarex Corporation | 2021-04-22 |
| 00840117305472 | Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric | Dynarex Corporation | 2021-04-22 |
| 00840117305458 | Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube | Dynarex Corporation | 2021-04-22 |
| 00840117305434 | Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port | Dynarex Corporation | 2021-04-22 |
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| 00840117305595 | Resp-O2 Universal 6" Flex Tube, Connector: 15F/22F | Dynarex Corporation | 2021-04-22 |
| 00840117305571 | Resp-O2 (HEPA) Respiratory BV Filter | Dynarex Corporation | 2021-04-22 |
| 00840117305496 | Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME) 50 | Dynarex Corporation | 2021-04-22 |
| 08717146000192 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000185 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000178 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000161 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000154 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000147 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000130 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000123 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000116 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000109 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000093 | Medisize® | Medisize B.V. | 2016-09-23 |