VITALOGRAPH-EC60 Hydrogen Monitor
FDA 510(k) K874892 · Vitalograph , Ltd.
510(k) numberK874892
Submission
- Device name
- VITALOGRAPH-EC60 Hydrogen Monitor
- Applicant
- Vitalograph , Ltd.
Lenexa, KS, US - Received
- December 1, 1987
- Decision date
- June 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| K942779 | Disposable Bacteriological FilterBZG · Traditional | 07/13/1994SE |
| K925085 | Escort SpirometerBZG · Traditional | 08/12/1993SE |
| K930085 | Vitalograph Data Storage SpirometerBTY · Traditional | 07/26/1993SE |
| K912412 | Vitalograph Spirotrac IIIBZG · Traditional | 10/15/1991SE |
Questions and answers
When was VITALOGRAPH-EC60 Hydrogen Monitor cleared by the FDA?
VITALOGRAPH-EC60 Hydrogen Monitor (K874892) received a 510(k) decision of Substantially Equivalent on June 2, 1988, 184 days after the submission was received.
What is the product code of K874892?
The FDA product code is NRH – System, Breath Measurement, a Class I (low risk) device regulated under 21 CFR 862.1820.