Spirovit SP-2, Pneumocheck II
FDA 510(k) K992823 · Schiller AG
510(k) numberK992823
Submission
- Device name
- Spirovit SP-2, Pneumocheck II
- Applicant
- Schiller AG
Baar, CH - Received
- August 23, 1999
- Decision date
- May 12, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Spirovit SP-2, Pneumocheck II cleared by the FDA?
Spirovit SP-2, Pneumocheck II (K992823) received a 510(k) decision of Substantially Equivalent on May 12, 2000, 263 days after the submission was received.
What is the product code of K992823?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.