Halolite Aad System with Dedicated Compressor
FDA 510(k) K991685 · Medic-Aid , Ltd.
510(k) numberK991685
Submission
- Device name
- Halolite Aad System with Dedicated Compressor
- Applicant
- Medic-Aid , Ltd.
Mccordsville, IN, US - Received
- May 17, 1999
- Decision date
- August 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K981772 | Halolite Aad SystemCAF · Traditional | 11/03/1998SE |
| K971933 | Port-NebCAF · Traditional | 08/01/1997SE |
| K934749 | Freeway Lite Nebulizer CompressorCAF · Traditional | 07/25/1994SE |
| K940888 | System 22 Paediatric MaskBYG · Traditional | 04/19/1994SE |
| K940887 | System 22 Adult MaskBYG · Traditional | 04/19/1994SE |
| K933535 | Ventstream Drug NebulizerCAF · Traditional | 01/24/1994SE |
| K924123 | Sidestream DisposableCAF · Traditional | 11/16/1992SE |
| K914152 | Sidestream Drug NebulizerCAF · Traditional | 05/05/1992SE |
Questions and answers
When was Halolite Aad System with Dedicated Compressor cleared by the FDA?
Halolite Aad System with Dedicated Compressor (K991685) received a 510(k) decision of Substantially Equivalent on August 13, 1999, 88 days after the submission was received.
What is the product code of K991685?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.