MICRO H2
FDA 510(k) clearance K963376 · decided 1997-01-24
Clearance details
- K-number
- K963376
- Device name
- MICRO H2
- Applicant
- Micro Direct, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-27
- Decision date
- 1997-01-24
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- NRH
- Device class
- 1
- Regulation number
- 862.1820
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Auburn, ME, 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 |
|---|---|---|
| MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY (K033688) | Micro Direct, Inc. | 2004-05-19 |
| JAYCO HYDROGEN MONITOR (K882499) | Enteron, Inc. | 1988-06-28 |
| VITALOGRAPH-EC60 HYDROGEN MONITOR (K874892) | Vitalograph , Ltd. | 1988-06-02 |
Recalls involving this device
No recalls on record reference this clearance.