OS-1 Occlusion System - 1
FDA 510(k) K894839 · Medical, Inc.
510(k) numberK894839
Submission
- Device name
- OS-1 Occlusion System - 1
- Applicant
- Medical, Inc.
Hatfield, PA, US - Received
- July 31, 1989
- Decision date
- October 24, 1989
- 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 OS-1 Occlusion System - 1 cleared by the FDA?
OS-1 Occlusion System - 1 (K894839) received a 510(k) decision of Substantially Equivalent on October 24, 1989, 85 days after the submission was received.
What is the product code of K894839?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.