510(k) K914283
- Device
- THAYER EXPANSION CHAMBER METERED DOSE INHALER
- Applicant
- THAYER MEDICAL CORP.
- 510(k) number
- K914283
- Product code
- CAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-26
- Date received
- 1991-09-24
- Regulation
- 868.5630
- Classification name
- Nebulizer (direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID SLADEK
- Address
- 4500 E. Speedway Blvd. Suite 20 Tucson AZ US 85712 85712
FDA Registration Numbers#
- 3009327812
- 3017200972
- 3033530347
- 3009057691
- 3007134734
- 1832562
- 3002806730
- 9710644
- 2085602
- 9710567
- 3012329712
- 3000126629
- 3014315664
- 3012307300
- 3002797442
- 3016088544
- 3006339858
- 3008806809
- 3001373226
- 3006467300
- 3007177643
- 3031369651
- 3010131137
- 3005569927
- 3017953405
- 8030673
- 1314417
- 1039215
- 3010713600
- 3010594263
- 3023272766
- 3005862821
- 1313525
- 9710391
- 2024500
- 3007502289
- 9616390
- 3004145393
- 3006157842
- 3003862188
- 3007384659
- 3001034529
- 1000604079
- 1317346
- 1417411
- 3010402691
- 2050098
- 3003622639
- 3005440755
- 3006061749
- 3033482477
- 3012316249
- 3013053058
- 3033332986
- 3010205626
- 3018783526
- 8043316
- 3012187635
- 3016360883
- 3011987967
- 9680741
- 3005669815
- 8030245
- 3003399703
- 3007344957
- 3031259044
- 2026894
- 3003767629
- 8022890
- 8043439
- 3011191255
- 3004022358
- 3012971441
- 9611045
- 3008789114
- 3010892830
- 1526863
- 3031506335
- 3003803075
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| K250022 | HeroTracker Sense | Voluntis | 2025-06-30 |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | 2025-04-29 |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | 2024-06-18 |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. | 2024-05-10 |
| K232523 | Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% | Mankind Pharma Limited | 2024-04-10 |
| K231058 | Hudson RCI® AddiPak® Unit Dose Vial | Medline Industries, LP | 2024-01-04 |
| K230379 | Portable (Ultrasonic) Nebulizer | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| K230602 | Hudson RCI® TurboMist™ Nebulizer System | Medline Industries, LP | 2023-10-31 |
| K223367 | Ochsner Connected Inhaler Sensor | Ochsner Clinic Foundation | 2023-08-30 |
| K220145 | Monaghan medical filtered mouthpiece kit | Monaghan Medical Corporation | 2023-08-24 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases