FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
K Number: K894667
·
Decision Oct 19, 1989
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
- K Number
- K894667
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Pneumedics, Inc.
- Date Received
- July 25, 1989
- Decision Date
- October 19, 1989
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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