S 22 Instrument Stand
FDA 510(k) K891584 · Carl Zeiss, Inc.
510(k) numberK891584
Submission
- Device name
- S 22 Instrument Stand
- Applicant
- Carl Zeiss, Inc.
Thornwood, NY, US - Received
- March 20, 1989
- Decision date
- June 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
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| K930439 | Marco Surgiscope Operation MicroscopesHRM · Traditional | Marco Ophthalmic, Inc. | 07/22/1993SE |
| K920641 | Alcon Operating MicroscopesHRM · Traditional | Alcon Laboratories | 10/09/1992SE |
| K914956 | Keeler Konan Specular Microscope SP5500HRM · Traditional | Keeler Instruments, Inc. | 02/03/1992SE |
| 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 S 22 Instrument Stand cleared by the FDA?
S 22 Instrument Stand (K891584) received a 510(k) decision of Substantially Equivalent on June 8, 1989, 80 days after the submission was received.
What is the product code of K891584?
The FDA product code is HRM – Microscope, Operating & Accessories, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 878.4700.