Rodenstock Scanning Laser Ophthalmoscope

FDA 510(k) K871268 · G. Rodenstock Instrumente GmbH

Substantially Equivalent

510(k) numberK871268

Submission

Device name
Rodenstock Scanning Laser Ophthalmoscope
Applicant
G. Rodenstock Instrumente GmbH
Munchen 70, West Germany, DE
Received
March 31, 1987
Decision date
June 10, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HLI – Ophthalmoscope, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

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Questions and answers

When was Rodenstock Scanning Laser Ophthalmoscope cleared by the FDA?

Rodenstock Scanning Laser Ophthalmoscope (K871268) received a 510(k) decision of Substantially Equivalent on June 10, 1987, 71 days after the submission was received.

What is the product code of K871268?

The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.