FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT VENTILATORY MEASUREMENT SYSTEM
K Number: K801497
·
Decision Oct 3, 1980
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
23
Review Days
99
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Basic Information
- Device Name
- INFANT VENTILATORY MEASUREMENT SYSTEM
- K Number
- K801497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Medical Graphics Corp.
- Date Received
- June 26, 1980
- Decision Date
- October 3, 1980
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
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