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FDA 510(k)

ED-344OT

K-Number: K961568 · 1996-07-09

ApplicantPentax Precision Instrument Corp.
Decision Date1996-07-09
Product CodeFDT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ED-344OT 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 1996-07-09 under 510(k) number K961568. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ED-344OT?

ED-344OT is a medical device that received FDA 510(k) clearance on 1996-07-09. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K961568.

When did ED-344OT receive FDA 510(k) clearance?

ED-344OT received FDA 510(k) clearance on 1996-07-09, under 510(k) number K961568.

Who is the listed applicant for ED-344OT?

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 ED-344OT?

The FDA product code for ED-344OT is FDT.

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-3630URK041396FG-36UX FIBER ULTRASOUND GASTROSCOPEK041397EG-3830UTK031789EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023401EG-3830UT, VIDEO ULTRASOUND GASTROSCOPEK023376EB-1830T3, VIDEO BRONCHOSCOPE

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Related Devices (Code: FDT)

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.

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm CorporationK253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

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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