Frantz Medical Electrode
FDA 510(k) K863508 · Frantz Medical Development, Ltd.
510(k) numberK863508
Submission
- Device name
- Frantz Medical Electrode
- Applicant
- Frantz Medical Development, Ltd.
New York, NY, US - Received
- September 9, 1986
- Decision date
- February 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXR – Ballistocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2320
- Specialty
- Cardiovascular
Other 510(k)s with product code DXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243566 | CardioTagDXR · Traditional | Cardiosense, Inc. | 07/22/2025SE |
| K160656 | CorSensDXR · Traditional | Corsens Medical , Ltd. | 11/21/2016SE |
| K081603 | Digital Ballistocardiograph, Model DGB 300DXR · Traditional | Heartforce Medical, Inc. | 07/24/2009SE |
| K870442 | QuantascopeDXR · Traditional | Vital Science Corp. | 08/11/1987SN |
More from Vital Science Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K981541 | Clearstar Enteral Nutrition PumpLZH · Traditional | 08/13/1998SE |
| K905282 | Endoscopic Accessory to the Light SourceGCT · Traditional | 03/19/1991SEKD |
| K873119 | Flexiflo Companion Enteral Nutrition PumpLZH · Traditional | 11/05/1987SE |
| K871710 | Biopsy ForcepsFCL · Traditional | 08/10/1987SE |
Questions and answers
When was Frantz Medical Electrode cleared by the FDA?
Frantz Medical Electrode (K863508) received a 510(k) decision of Substantially Equivalent on February 6, 1987, 150 days after the submission was received.
What is the product code of K863508?
The FDA product code is DXR – Ballistocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2320.