GM Opti*Cam Camera with Fiber Optic Light
FDA 510(k) K941660 · Gm Engineering, Inc.
510(k) numberK941660
Submission
- Device name
- GM Opti*Cam Camera with Fiber Optic Light
- Applicant
- Gm Engineering, Inc.
La Verne, CA, US - Received
- April 5, 1994
- Decision date
- May 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYH – Endoscope, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K933962 | GM Continuous Flow Biopsy ProbeFDC · Traditional | 02/25/1994SE |
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Questions and answers
When was GM Opti*Cam Camera with Fiber Optic Light cleared by the FDA?
GM Opti*Cam Camera with Fiber Optic Light (K941660) received a 510(k) decision of Substantially Equivalent on May 24, 1994, 49 days after the submission was received.
What is the product code of K941660?
The FDA product code is KYH – Endoscope, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.