THE HEART PROTECTOR
FDA 510(k) clearance K944481 · decided 1995-04-10
Clearance details
- K-number
- K944481
- Device name
- THE HEART PROTECTOR
- Applicant
- Garan Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-13
- Decision date
- 1995-04-10
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- NXB
- Device class
- 1
- Regulation number
- 890.5050
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Morristown, NJ, 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 |
|---|---|---|
| TAB PAK (K882731) | Dynex Trading Co. | 1988-12-14 |
| NITROGLYCERINE CONTAINER (K833311) | Apothecary Products, Inc. | 1984-02-04 |
Recalls involving this device
No recalls on record reference this clearance.