Alcon Operating Microscopes
FDA 510(k) K920641 · Alcon Laboratories
510(k) numberK920641
Submission
- Device name
- Alcon Operating Microscopes
- Applicant
- Alcon Laboratories
Fort Worth, TX, US - Received
- February 12, 1992
- Decision date
- October 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4700
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K932720 | HM-0970HRM · Traditional | Hill-Med, Inc. | 09/07/1993SE |
| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | Marco Ophthalmic, Inc. | 07/22/1993SE |
| K914956 | Keeler Konan Specular Microscope SP5500HRM · Traditional | Keeler Instruments, Inc. | 02/03/1992SE |
| K891584 | S 22 Instrument StandHRM · Traditional | Carl Zeiss, Inc. | 06/08/1989SE |
| K891001 | Microscope Knob Cover, Sterile, DisposableHRM · Traditional | Prescott'S, Inc. | 04/11/1989SE |
| K854440 | Modified Clinical Widefield Specular Microscope 50HRM · Traditional | Keeler Instruments, Inc. | 12/16/1985SE |
| K853855 | Xtal X-150 Operating MicroscopeHRM · Traditional | Xtal Corp. | 10/15/1985SE |
| K852586 | Cromic Surgical Microscope Model MC-1HRM · Traditional | Seltrex, Corp. | 07/30/1985SE |
| K852150 | Clinical Widefield Specular Micriscope 500HRM · Traditional | Keeler Instruments, Inc. | 06/03/1985SE |
| K850270 | Corneal Light ShieldHRM · Traditional | Mentor O & O, Inc. | 05/31/1985SE |
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Questions and answers
When was Alcon Operating Microscopes cleared by the FDA?
Alcon Operating Microscopes (K920641) received a 510(k) decision of Substantially Equivalent on October 9, 1992, 240 days after the submission was received.
What is the product code of K920641?
The FDA product code is HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 878.4700.