510(k) K822835
K822835 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "PZ-800 VOLUME VENTILATOR". The FDA issued a decision of Substantially Equivalent on Sep 29, 1983. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Narco Scientific has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 29, 1983
- Date Received
- Sep 21, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
- 510(k)