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FDA 510(k)

CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE

K-Number: K932259 · 1993-12-15

ApplicantClarus Medical Systems, Inc.
Decision Date1993-12-15
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Clarus Medical Systems, Inc.. It received FDA 510(k) clearance on 1993-12-15 under 510(k) number K932259. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE?

CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE is a medical device that received FDA 510(k) clearance on 1993-12-15. The listed applicant is Clarus Medical Systems, Inc.. The 510(k) number is K932259.

When did CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE receive FDA 510(k) clearance?

CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE received FDA 510(k) clearance on 1993-12-15, under 510(k) number K932259.

Who is the listed applicant for CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE?

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

What is the FDA product code for CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE?

The FDA product code for CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE is ERA.

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Other records listing Clarus Medical Systems, 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.

K980588CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000K974579PERCSCOPE MODEL 2600K971584CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES)K971455CLARUS MODEL 5197 SIGHTLITEK960915CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXXK962255CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)

View all 22 devices →

Related Devices (Code: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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.

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