Qualitative Keratometer M823 with Power Supply
FDA 510(k) K911062 · Storz Instrument Co.
510(k) numberK911062
Submission
- Device name
- Qualitative Keratometer M823 with Power Supply
- Applicant
- Storz Instrument Co.
St. Louis, MO, US - Received
- March 11, 1991
- Decision date
- May 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNO – Keratome, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
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Questions and answers
When was Qualitative Keratometer M823 with Power Supply cleared by the FDA?
Qualitative Keratometer M823 with Power Supply (K911062) received a 510(k) decision of Substantially Equivalent on May 22, 1991, 72 days after the submission was received.
What is the product code of K911062?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.