510(k) K915750
K915750 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "DISPOSABLE BACTERIAL BREATHNG FILTER". The FDA issued a decision of Substantially Equivalent on November 30, 1994. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Hospitak, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1994
- Date Received
- December 19, 1991
- 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