Screening Computeo SC-20
FDA 510(k) K771371 · Cavitron Corp.
510(k) numberK771371
Submission
- Device name
- Screening Computeo SC-20
- Applicant
- Cavitron Corp.
Mchenry, IL, US - Received
- July 25, 1977
- Decision date
- August 4, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZM – Calculator, Pulmonary Function Interpretor (Diagnostic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1900
- Specialty
- Anesthesiology
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Questions and answers
When was Screening Computeo SC-20 cleared by the FDA?
Screening Computeo SC-20 (K771371) received a 510(k) decision of Substantially Equivalent on August 4, 1977, 10 days after the submission was received.
What is the product code of K771371?
The FDA product code is BZM – Calculator, Pulmonary Function Interpretor (Diagnostic), a Class II (moderate risk) device regulated under 21 CFR 868.1900.