Micro H2
FDA 510(k) K963376 · Micro Direct, Inc.
510(k) numberK963376
Submission
- Device name
- Micro H2
- Applicant
- Micro Direct, Inc.
Auburn, ME, US - Received
- August 27, 1996
- Decision date
- January 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NRH – System, Breath Measurement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1820
- Specialty
- Clinical Chemistry
Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.
Other 510(k)s with product code NRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033688 | Micro H2 Breath Monitoring Device with Hydra Software UtilityNRH · Traditional | Micro Direct, Inc. | 05/19/2004SE |
| K882499 | Jayco Hydrogen MonitorNRH · Traditional | Enteron, Inc. | 06/28/1988SE |
| K874892 | VITALOGRAPH-EC60 Hydrogen MonitorNRH · Traditional | Vitalograph , Ltd. | 06/02/1988SE |
More from Vitalograph , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033688 | Micro H2 Breath Monitoring Device with Hydra Software UtilityNRH · Traditional | 05/19/2004SE |
| K031102 | Microlab SpirometerBZG · Traditional | 12/01/2003SE |
| K030586 | MicropeakBZH · Traditional | 08/27/2003SE |
| K973314 | Spirosafe FilterCAH · Traditional | 11/21/1997SE |
| K965042 | Microdl Diarycard SpirometerBZG · Traditional | 06/17/1997SE |
| K963035 | Micro SpirometerBZG · Traditional | 11/01/1996SE |
| K950197 | MicrocoCCJ · Traditional | 10/17/1996SE |
| K940375 | Micro MPMCAP · Traditional | 11/21/1994SE |
Questions and answers
When was Micro H2 cleared by the FDA?
Micro H2 (K963376) received a 510(k) decision of Substantially Equivalent on January 24, 1997, 150 days after the submission was received.
What is the product code of K963376?
The FDA product code is NRH – System, Breath Measurement, a Class I (low risk) device regulated under 21 CFR 862.1820.