Argon Laser Photocoagulator Sys Repeat Mode
FDA 510(k) K844198 · Nidek, Inc.
510(k) numberK844198
Submission
- Device name
- Argon Laser Photocoagulator Sys Repeat Mode
- Applicant
- Nidek, Inc.
Palo Alto, CA, US - Received
- October 30, 1984
- Decision date
- December 24, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQB – Photocoagulator And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4690
- Specialty
- Ophthalmic
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Questions and answers
When was Argon Laser Photocoagulator Sys Repeat Mode cleared by the FDA?
Argon Laser Photocoagulator Sys Repeat Mode (K844198) received a 510(k) decision of Substantially Equivalent on December 24, 1984, 55 days after the submission was received.
What is the product code of K844198?
The FDA product code is HQB – Photocoagulator And Accessories, a Class II (moderate risk) device regulated under 21 CFR 886.4690.