Angioscan (AS Stand Alone Instrument)
FDA 510(k) K951132 · Carl Zeiss Meditec, Inc.
510(k) numberK951132
Submission
- Device name
- Angioscan (AS Stand Alone Instrument)
- Applicant
- Carl Zeiss Meditec, Inc.
San Diego, CA, US - Received
- March 13, 1995
- Decision date
- June 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 Angioscan (AS Stand Alone Instrument) cleared by the FDA?
Angioscan (AS Stand Alone Instrument) (K951132) received a 510(k) decision of Substantially Equivalent on June 26, 1995, 105 days after the submission was received.
What is the product code of K951132?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.