510(k) K961838
K961838 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "RESPIRGARD II, SPIROGARD". The FDA issued a decision of Substantially Equivalent on October 18, 1996. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 18, 1996
- Date Received
- May 13, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Bacterial, Breathing-Circuit
- Device Class
- Class II
- Regulation Number
- 868.5260
- Review Panel
- HO
- Submission Type