Magnetron Munich Model Electronic Control Unit
FDA 510(k) K894511 · Intl. Ophthalmic Industries Corp.
510(k) numberK894511
Submission
- Device name
- Magnetron Munich Model Electronic Control Unit
- Applicant
- Intl. Ophthalmic Industries Corp.
Weston, MA, US - Received
- July 19, 1989
- Decision date
- October 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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| K791763 | (Micro-Keratron, Micro Duct Trephine)HRG · Traditional | 11/05/1979SE |
Questions and answers
When was Magnetron Munich Model Electronic Control Unit cleared by the FDA?
Magnetron Munich Model Electronic Control Unit (K894511) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 90 days after the submission was received.
What is the product code of K894511?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.