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FDA 510(k)

FE-34TH, FIBER ESOPHAGOSCOPE

K-Number: K951198 · 1995-05-30

ApplicantPentax Precision Instrument Corp.
Decision Date1995-05-30
Product CodeGCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FE-34TH, FIBER ESOPHAGOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Pentax Precision Instrument Corp.. It received FDA 510(k) clearance on 1995-05-30 under 510(k) number K951198. The device is classified under product code GCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FE-34TH, FIBER ESOPHAGOSCOPE?

FE-34TH, FIBER ESOPHAGOSCOPE is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K951198.

When did FE-34TH, FIBER ESOPHAGOSCOPE receive FDA 510(k) clearance?

FE-34TH, FIBER ESOPHAGOSCOPE received FDA 510(k) clearance on 1995-05-30, under 510(k) number K951198.

Who is the listed applicant for FE-34TH, FIBER ESOPHAGOSCOPE?

The FDA 510(k) record lists Pentax Precision Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FE-34TH, FIBER ESOPHAGOSCOPE?

The FDA product code for FE-34TH, FIBER ESOPHAGOSCOPE is GCL.

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Other records listing Pentax Precision Instrument Corp. 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.

K041395EG-3630URK041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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Related Devices (Code: GCL)

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.

K951197FE-24X, FIBER ESOPHAGOSCOPEPentax Precision Instrument Corp.K9345105,6,7,9,10,11,12MM BLUNT-TIP TROCAR OBTUR/THREADPhx Technologies Corp.K922086BARD BIOPSY FORCEPSC.R. Bard, 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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