510(k) K770245
K770245 is an FDA 510(k) premarket notification submitted by Mennen Greatbatch Electonics for the device "ABDOMINAL FETAL ECG MODULE". The FDA issued a decision of Substantially Equivalent on February 14, 1977. The device falls under product code KXN (Monitor, Cardiac, Fetal), a Class II device regulated under 21 CFR 884.2600. 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
- Monitor, Cardiac, Fetal
- Device Class
- Class II
- Regulation Number
- 884.2600
- Review Panel
- OB
- Submission Type