FRANTZ MEDICAL ELECTRODE
FDA 510(k) clearance K863508 · decided 1987-02-06
Clearance details
- K-number
- K863508
- Device name
- FRANTZ MEDICAL ELECTRODE
- Applicant
- Frantz Medical Development, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-09
- Decision date
- 1987-02-06
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- DXR
- Device class
- 2
- Regulation number
- 870.2320
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- New York, NY, 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 |
|---|---|---|
| CardioTag™ (K243566) | Cardiosense, Inc. | 2025-07-22 |
| CorSens (K160656) | Corsens Medical , Ltd. | 2016-11-21 |
| DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 (K081603) | Heartforce Medical, Inc. | 2009-07-24 |
| QUANTASCOPE (K870442) | Vital Science Corp. | 1987-08-11 |
Recalls involving this device
No recalls on record reference this clearance.