510(k) K792283
K792283 is an FDA 510(k) premarket notification submitted by Arzbaecher & Co. for the device "ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON". The FDA issued a decision of Substantially Equivalent on Nov 21, 1979. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Arzbaecher & Co. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 21, 1979
- Date Received
- Nov 13, 1979
- 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)