Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OPMI CS

K-Number: K883581 · 1988-09-13

ApplicantCarl Zeiss, Inc.
Decision Date1988-09-13
Product CodeEPT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPMI CS is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1988-09-13 under 510(k) number K883581. The device is classified under product code EPT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPMI CS?

OPMI CS is a medical device that received FDA 510(k) clearance on 1988-09-13. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K883581.

When did OPMI CS receive FDA 510(k) clearance?

OPMI CS received FDA 510(k) clearance on 1988-09-13, under 510(k) number K883581.

Who is the listed applicant for OPMI CS?

The FDA 510(k) record lists Carl Zeiss, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPMI CS?

The FDA product code for OPMI CS is EPT.

Other records listing Carl Zeiss, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K013402VISULAS 532SK003885VISULAS YAG IIK993357IOLMASTERK983868OPMI TWINER SURGICAL MICROSCOPEK965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEMK961380CPC PROBE

View all 44 devices →

Related Devices (Code: EPT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942233MKM (MULTIPLE COORDINATE MANIPULATOR) SYSTEMCarl Zeiss, Inc.K931284MICRODYNE OFFICE SURGICAL MICROSCOPEMicrodyne, Inc.K933310MICRINS CONTRAST BACKGROUND MATERIALMicrins Surgical, Inc.K903412STORZ MODEL M705 AND/OR M706 CEILING MOUNTED MICR.Storz Instrument Co.K882269STORZ DIAGNOSTIC MICROSCOPE SYSTEMStorz Instrument Co.K860811ZEISS VOICE CONTROL SYSTEM FOR OPMI'SCarl Zeiss, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑