FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K Number: K905397
·
Decision May 14, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
22
Applicant Total
110
Review Days
165
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Basic Information
- Device Name
- PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
- K Number
- K905397
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1200
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Puritan Bennett Corp.
- Date Received
- November 30, 1990
- Decision Date
- May 14, 1991
- Product Code
- CCE
- 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 |
|---|---|---|---|
| CCE | Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling | FDA class 2 | Anesthesiology |
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