510(k) K991788
- Device
- SALTER LABS PEP DEVICE
- Applicant
- SALTER LABS
- 510(k) number
- K991788
- Product code
- CAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-08-06
- Date received
- 1999-05-25
- Regulation
- 868.5630
- Classification name
- Nebulizer (direct Patient Interface)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DUANE KAZAL
- Address
- 100 W. Sycamore Rd. Arvin CA US 93203 93203
FDA Registration Numbers#
- 3004748541
- 3044994756
- 2026894
- 3030446844
- 2515872
- 3012307300
- 3020460367
- 3006157842
- 3017207990
- 8022032
- 3010272829
- 9616843
- 3001373226
- 3003803075
- 3003862188
- 3010042047
- 1039215
- 3015142935
- 2518443
- 3031369651
- 3004145393
- 3012971441
- 3006606984
- 3007740533
- 3012316249
- 3008702754
- 3033482477
- 3009683397
- 3006446479
- 3011189029
- 8044169
- 3010047139
- 3013530341
- 9710644
- 9617604
- 3029227324
- 3030733800
- 2938401
- 3010205626
- 3005569927
- 2518422
- 3020638914
- 8022890
- 3003622639
- 8021995
- 3005998497
- 9612777
- 3010834934
- 8030245
- 3008220943
- 3006783791
- 9611451
- 3004443928
- 8043439
- 3018782623
- 3043460907
- 3016088544
- 3005862821
- 3018783526
- 3003767629
- 3014499739
- 8022077
- 9610861
- 3016750005
- 2028807
- 9611045
- 3006500694
- 3010287621
- 3000126629
- 3010880718
- 8043510
- 3001034529
- 3005669815
- 9710391
- 3007384659
- 3007177643
- 3009095356
- 3015058854
- 3021244152
Source Documents#
Other 510(k) Records For Product Code CAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | 2026-06-02 |
| 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 |
Legacy Summary#
summary
FDA Review#
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