Spirolite Model MSC-201 Spirometer
FDA 510(k) K921513 · Medical Systems Corp.
510(k) numberK921513
Submission
- Device name
- Spirolite Model MSC-201 Spirometer
- Applicant
- Medical Systems Corp.
Greenvale, NY, US - Received
- March 31, 1992
- Decision date
- January 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was Spirolite Model MSC-201 Spirometer cleared by the FDA?
Spirolite Model MSC-201 Spirometer (K921513) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 302 days after the submission was received.
What is the product code of K921513?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.