PB3200 Intra-Arterial Blood Gas Monitoring System
FDA 510(k) K905397 · Puritan Bennett Corp.
510(k) numberK905397
Submission
- Device name
- PB3200 Intra-Arterial Blood Gas Monitoring System
- Applicant
- Puritan Bennett Corp.
Overland Park, KS, US - Received
- November 30, 1990
- Decision date
- May 14, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
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Questions and answers
When was PB3200 Intra-Arterial Blood Gas Monitoring System cleared by the FDA?
PB3200 Intra-Arterial Blood Gas Monitoring System (K905397) received a 510(k) decision of Substantially Equivalent on May 14, 1991, 165 days after the submission was received.
What is the product code of K905397?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.