FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALOGRAPH MICRO
K Number: K991412
·
Decision Feb 4, 2000
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
79
Applicant Total
5
Review Days
287
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Basic Information
- Device Name
- VITALOGRAPH MICRO
- K Number
- K991412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vitalograph, Inc.
- Date Received
- April 23, 1999
- Decision Date
- February 4, 2000
- Product Code
- BZH
- 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 |
|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | FDA class 2 | Anesthesiology |
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Other Clearances by Vitalograph, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K000599 | VITALOGRAPH BASE STATION | Sep 8, 2000 | Substantially Equivalent |
| K943678 | ELECTRONIC FLOW METER | Dec 14, 1995 | Substantially Equivalent |
| K946075 | VITALOGRAPH MODEL 2120 | Aug 4, 1995 | Substantially Equivalent |
| K942779 | DISPOSABLE BACTERIOLOGICAL FILTER | Jul 13, 1994 | Substantially Equivalent |