510(k) K792373
K792373 is an FDA 510(k) premarket notification submitted by Ipco Corp. for the device "IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code DXK (Echocardiograph), a Class II device regulated under 21 CFR 870.2330. Ipco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1980
- Date Received
- November 26, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Echocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2330
- Review Panel
- CV
- Submission Type