MVP - 6000
FDA 510(k) K852909 · Waters Instruments, Inc.
510(k) numberK852909
Submission
- Device name
- MVP - 6000
- Applicant
- Waters Instruments, Inc.
Rochester, MN, US - Received
- July 9, 1985
- Decision date
- November 14, 1985
- 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 MVP - 6000 cleared by the FDA?
MVP - 6000 (K852909) received a 510(k) decision of Substantially Equivalent on November 14, 1985, 128 days after the submission was received.
What is the product code of K852909?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.