510(k) K822216
K822216 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "VOLUMETRIC CONTROLLER". The FDA issued a decision of Substantially Equivalent on August 16, 1982. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1982
- Date Received
- July 26, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bag, Reservoir
- Device Class
- Class I
- Regulation Number
- 868.5320
- Review Panel
- AN
- Submission Type