510(k) K991685
K991685 is an FDA 510(k) premarket notification submitted by Medic-Aid , Ltd. for the device "HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR". The FDA issued a decision of Substantially Equivalent on August 13, 1999. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medic-Aid , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1999
- Date Received
- May 17, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nebulizer (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type