Compumed Pulmonary Function Analyzer Model 307B
FDA 510(k) K854626 · Compumed, Inc.
510(k) numberK854626
Submission
- Device name
- Compumed Pulmonary Function Analyzer Model 307B
- Applicant
- Compumed, Inc.
Culver City, CA, US - Received
- November 18, 1985
- Decision date
- February 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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Questions and answers
When was Compumed Pulmonary Function Analyzer Model 307B cleared by the FDA?
Compumed Pulmonary Function Analyzer Model 307B (K854626) received a 510(k) decision of Substantially Equivalent on February 28, 1986, 102 days after the submission was received.
What is the product code of K854626?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.