510(k) K801680
K801680 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "BETA-CAP II ADAPTER". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code GCE (Adaptor, Catheter), a Class I device regulated under 21 CFR 878.4200. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1980
- Date Received
- July 22, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Catheter
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type