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FDA 510(k)

OSMOMETER MODEL OM-6010

K-Number: K811179 · 1981-05-15

ApplicantFiske Med Science
Decision Date1981-05-15
Product CodeJJM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OSMOMETER MODEL OM-6010 is the device name listed in this FDA 510(k) record. The listed applicant is Fiske Med Science. It received FDA 510(k) clearance on 1981-05-15 under 510(k) number K811179. The device is classified under product code JJM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSMOMETER MODEL OM-6010?

OSMOMETER MODEL OM-6010 is a medical device that received FDA 510(k) clearance on 1981-05-15. The listed applicant is Fiske Med Science. The 510(k) number is K811179.

When did OSMOMETER MODEL OM-6010 receive FDA 510(k) clearance?

OSMOMETER MODEL OM-6010 received FDA 510(k) clearance on 1981-05-15, under 510(k) number K811179.

Who is the listed applicant for OSMOMETER MODEL OM-6010?

The FDA 510(k) record lists Fiske Med Science as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSMOMETER MODEL OM-6010?

The FDA product code for OSMOMETER MODEL OM-6010 is JJM.

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Related Devices (Code: JJM)

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.

K965036THE ADVANCED OSMOMETER (3900)Advanced Instruments, Inc.K962056ADVANCED MICRO-OSMOMETER MODEL 3300Advanced Instruments, Inc.K925970MODEL 3D3 OSMOMETERAdvanced Instruments, Inc.K911092OSMOMETER MODEL 2400Advanced Instruments, Inc.K873642OSMOMETER MODEL 110Advanced Instruments, Inc.K843997AO-10 AUTOMATED OSMOMETERbioMerieux, Inc.

Official Source

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

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