510(k) K802282
K802282 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON". The FDA issued a decision of Substantially Equivalent on Oct 10, 1980. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Consolidated Medical Equipment, Inc. has 14 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 10, 1980
- Date Received
- Sep 19, 1980
- 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)