510(k) K790203
K790203 is an FDA 510(k) premarket notification submitted by Electronics For Medicine, Inc. for the device "INTERVAL TIMER MODEL V4295". The FDA issued a decision of Substantially Equivalent on March 2, 1979. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Electronics For Medicine, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1979
- Date Received
- January 30, 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