510(k) K770247
K770247 is an FDA 510(k) premarket notification submitted by Mennen Greatbatch Electonics for the device "D.C. AMPLIFIER MODULE". The FDA issued a decision of Substantially Equivalent on February 14, 1977. The device falls under product code DRQ (Amplifier And Signal Conditioner, Transducer Signal), a Class II device regulated under 21 CFR 870.2060. Mennen Greatbatch Electonics has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1977
- Date Received
- February 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amplifier And Signal Conditioner, Transducer Signal
- Device Class
- Class II
- Regulation Number
- 870.2060
- Review Panel
- CV
- Submission Type