510(k) K944532
K944532 is an FDA 510(k) premarket notification submitted by Prima, Inc. for the device "PRIMA, INC. VENTILATOR HOSES". The FDA issued a decision of Substantially Equivalent on December 2, 1994. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Prima, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1994
- Date Received
- September 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Airway (Extension)
- Device Class
- Class I
- Regulation Number
- 868.5810
- Review Panel
- AN
- Submission Type