Panels › Clinical Chemistry › Product code NRH · Class 1
System, Breath Measurement
Regulation 862.1820
0510(k)s in 12 months (4 all time)
3recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in NRH
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 3 |
| Micro Direct, Inc. | 2 | 0 |
| Enteron, Inc. | 1 | 0 |
| Vitalograph , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2004 | K033688 | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY Micro Direct, Inc. | NRH |
| Jan 24, 1997 | K963376 | MICRO H2 Micro Direct, Inc. | NRH |
| Jun 28, 1988 | K882499 | JAYCO HYDROGEN MONITOR Enteron, Inc. | NRH |
| Jun 2, 1988 | K874892 | VITALOGRAPH-EC60 HYDROGEN MONITOR Vitalograph , Ltd. | NRH |
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