510(k) K780572

DCG PREAMPLIFIER MODULE by C-V Monitors Corp. — Product Code DRR

K780572 is an FDA 510(k) premarket notification submitted by C-V Monitors Corp. for the device "DCG PREAMPLIFIER MODULE". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. C-V Monitors Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1978
Date Received
April 10, 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