510(k) K853737
K853737 is an FDA 510(k) premarket notification submitted by Capintec, Inc. for the device "VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)". The FDA issued a decision of Substantially Equivalent on February 13, 1986. The device falls under product code IYY (Synchronizer, Electrocardiograph, Nuclear), a Class I device regulated under 21 CFR 892.1410. Capintec, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1986
- Date Received
- September 6, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Synchronizer, Electrocardiograph, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1410
- Review Panel
- RA
- Submission Type