A O Fiber Optic Illuminator, 1185B
FDA 510(k) K821754 · Warner-Lambert Co.
510(k) numberK821754
Submission
- Device name
- A O Fiber Optic Illuminator, 1185B
- Applicant
- Warner-Lambert Co.
Mchenry, IL, US - Received
- June 15, 1982
- Decision date
- June 24, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCR – Light Source, Photographic, Fiberoptic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was A O Fiber Optic Illuminator, 1185B cleared by the FDA?
A O Fiber Optic Illuminator, 1185B (K821754) received a 510(k) decision of Substantially Equivalent on June 24, 1982, 9 days after the submission was received.
What is the product code of K821754?
The FDA product code is FCR – Light Source, Photographic, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 876.1500.