ABDOMINAL FETAL ECG MODULE
FDA 510(k) clearance K770245 · decided 1977-02-14
Clearance details
- K-number
- K770245
- Device name
- ABDOMINAL FETAL ECG MODULE
- Applicant
- Mennen Greatbatch Electonics
- Decision
- Substantially Equivalent
- Date received
- 1977-02-07
- Decision date
- 1977-02-14
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- KXN
- Device class
- 2
- Regulation number
- 884.2600
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CENTRAL STATION REPEATER (MODEL 8032A) (K760968) | Hewlett-Packard Co. | 1976-12-17 |
Recalls involving this device
No recalls on record reference this clearance.