Keeler Konan Specular Microscope SP3300
FDA 510(k) K900111 · Keeler Instruments, Inc.
510(k) numberK900111
Submission
- Device name
- Keeler Konan Specular Microscope SP3300
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- January 9, 1990
- Decision date
- March 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
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Questions and answers
When was Keeler Konan Specular Microscope SP3300 cleared by the FDA?
Keeler Konan Specular Microscope SP3300 (K900111) received a 510(k) decision of Substantially Equivalent on March 23, 1990, 73 days after the submission was received.
What is the product code of K900111?
The FDA product code is HLI – Ophthalmoscope, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.