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FDA 510(k)

PENTAX FG-34JA GASTROFIBERSCOPE

K-Number: K832007 · 1983-08-11

ApplicantPentax Precision Instrument Corp.
Decision Date1983-08-11
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENTAX FG-34JA GASTROFIBERSCOPE 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 1983-08-11 under 510(k) number K832007. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENTAX FG-34JA GASTROFIBERSCOPE?

PENTAX FG-34JA GASTROFIBERSCOPE is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K832007.

When did PENTAX FG-34JA GASTROFIBERSCOPE receive FDA 510(k) clearance?

PENTAX FG-34JA GASTROFIBERSCOPE received FDA 510(k) clearance on 1983-08-11, under 510(k) number K832007.

Who is the listed applicant for PENTAX FG-34JA GASTROFIBERSCOPE?

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 PENTAX FG-34JA GASTROFIBERSCOPE?

The FDA product code for PENTAX FG-34JA GASTROFIBERSCOPE is FDS.

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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.

K041397EG-3830UTK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041395EG-3630URK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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Related Devices (Code: FDS)

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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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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