60 Fundus Camera CF-60UV
FDA 510(k) K901839 · Canon USA, Inc.
510(k) numberK901839
Submission
- Device name
- 60 Fundus Camera CF-60UV
- Applicant
- Canon USA, Inc.
Jericho, NY, US - Received
- April 24, 1990
- Decision date
- July 5, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HJI – Lens, Fundus, Hruby, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1395
- Specialty
- Ophthalmic
Other 510(k)s with product code HJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923670 | Byrne Expulsive LensHJI · Traditional | Ocular Instruments, Inc. | 11/16/1992SE |
| K902138 | Stripe ProjectorHJI · Traditional | Academic Catalyst Corp. | 07/05/1990SE |
| K897186 | Laser Imaging Work StationHJI · Traditional | Innovision Medical, Inc. | 03/12/1990SE |
| K820223 | Oms Quartz Infusion Contact LensHJI · Traditional | Optical Micro Systems, Inc. | 02/05/1982SE |
| K802971 | Landers Contact LensHJI · Traditional | Cooper Medical Devices Corp. | 02/05/1981SE |
| K802927 | Sebestyen Irrigating Contact LensHJI · Traditional | Cooper Medical Devices Corp. | 02/05/1981SE |
| K760949 | Charles Irrigating Fundus Contact LensHJI · Traditional | Richard'S Medical Equip., Inc. | 11/11/1976SE |
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Questions and answers
When was 60 Fundus Camera CF-60UV cleared by the FDA?
60 Fundus Camera CF-60UV (K901839) received a 510(k) decision of Substantially Equivalent on July 5, 1990, 72 days after the submission was received.
What is the product code of K901839?
The FDA product code is HJI – Lens, Fundus, Hruby, Diagnostic, a Class I (low risk) device regulated under 21 CFR 886.1395.