510(k) K770245
- Device
- ABDOMINAL FETAL ECG MODULE
- Applicant
- Mennen Greatbatch Electonics
- 510(k) number
- K770245
- Product code
- KXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-14
- Date received
- 1977-02-07
- Regulation
- 884.2600
- Classification name
- Monitor, Cardiac, Fetal
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760968 | CENTRAL STATION REPEATER (MODEL 8032A) | Hewlett-Packard Co. | 1976-12-17 |