Aspiration Reversal Control (Arc) Module
FDA 510(k) K870068 · Optical Micro Systems, Inc.
510(k) numberK870068
Submission
- Device name
- Aspiration Reversal Control (Arc) Module
- Applicant
- Optical Micro Systems, Inc.
Danvers, MA, US - Received
- January 8, 1987
- Decision date
- February 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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Questions and answers
When was Aspiration Reversal Control (Arc) Module cleared by the FDA?
Aspiration Reversal Control (Arc) Module (K870068) received a 510(k) decision of Substantially Equivalent on February 12, 1987, 35 days after the submission was received.
What is the product code of K870068?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.