FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO H2
K Number: K963376
·
Decision Jan 24, 1997
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
9
Review Days
150
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Basic Information
- Device Name
- MICRO H2
- K Number
- K963376
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1820
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Micro Direct, Inc.
- Date Received
- August 27, 1996
- Decision Date
- January 24, 1997
- Product Code
- NRH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NRH | System, Breath Measurement | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NRH), ordered by most recent decision date.
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JAYCO HYDROGEN MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITALOGRAPH-EC60 HYDROGEN MONITOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Micro Direct, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033688 | MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY | May 19, 2004 | Substantially Equivalent |
| K031102 | MICROLAB SPIROMETER | Dec 1, 2003 | Substantially Equivalent |
| K030586 | MICROPEAK | Aug 27, 2003 | Substantially Equivalent |
| K973314 | SPIROSAFE FILTER | Nov 21, 1997 | Substantially Equivalent |
| K965042 | MICRODL DIARYCARD SPIROMETER | Jun 17, 1997 | Substantially Equivalent |
| K963035 | MICRO SPIROMETER | Nov 1, 1996 | Substantially Equivalent |
| K950197 | MICROCO | Oct 17, 1996 | Substantially Equivalent |
| K940375 | MICRO MPM | Nov 21, 1994 | Substantially Equivalent |