510(k) K780043
K780043 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "ESIS MODULE". The FDA issued a decision of Substantially Equivalent on Feb 13, 1978. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Datascope Corp. has 135 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 13, 1978
- Date Received
- Jan 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Amplifier And Signal Conditioner, Biopotential
- Device Class
- Class II
- Regulation Number
- 870.2050
- Review Panel
- CV
- Submission Type
- 510(k)