Inspiron Pulmonary Function Analyzer
FDA 510(k) K802920 · C.R. Bard, Inc.
510(k) numberK802920
Submission
- Device name
- Inspiron Pulmonary Function Analyzer
- Applicant
- C.R. Bard, Inc.
Mchenry, IL, US - Received
- November 18, 1980
- Decision date
- February 23, 1981
- 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 Inspiron Pulmonary Function Analyzer cleared by the FDA?
Inspiron Pulmonary Function Analyzer (K802920) received a 510(k) decision of Substantially Equivalent on February 23, 1981, 97 days after the submission was received.
What is the product code of K802920?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.