FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
K Number: K033688
·
Decision May 19, 2004
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
9
Review Days
177
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Basic Information
- Device Name
- MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITY
- K Number
- K033688
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1820
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Direct, Inc.
- Date Received
- November 24, 2003
- Decision Date
- May 19, 2004
- 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
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 | ||
|---|---|---|---|
| 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 |
| K963376 | MICRO H2 | Jan 24, 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 |