Med. Dynamics Satican Video Camera 5410
FDA 510(k) K843294 · Medline Industries, Inc.
510(k) numberK843294
Submission
- Device name
- Med. Dynamics Satican Video Camera 5410
- Applicant
- Medline Industries, Inc.
Englewood, CO, US - Received
- August 21, 1984
- Decision date
- December 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQM – Camera, Surgical And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Med. Dynamics Satican Video Camera 5410 cleared by the FDA?
Med. Dynamics Satican Video Camera 5410 (K843294) received a 510(k) decision of Substantially Equivalent on December 12, 1984, 113 days after the submission was received.
What is the product code of K843294?
The FDA product code is KQM – Camera, Surgical And Accessories, a Class I (low risk) device regulated under 21 CFR 878.4160.