FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRODL DIARYCARD SPIROMETER
K Number: K965042
·
Decision Jun 17, 1997
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
9
Review Days
182
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Basic Information
- Device Name
- MICRODL DIARYCARD SPIROMETER
- K Number
- K965042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micro Direct, Inc.
- Date Received
- December 17, 1996
- Decision Date
- June 17, 1997
- Product Code
- BZG
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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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 |
| 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 |