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FDA 510(k)

FI-10P

K-Number: K951195 · 1995-04-06

ApplicantPentax Precision Instrument Corp.
Decision Date1995-04-06
Product CodeCAL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FI-10P 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 1995-04-06 under 510(k) number K951195. The device is classified under product code CAL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FI-10P?

FI-10P is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Pentax Precision Instrument Corp.. The 510(k) number is K951195.

When did FI-10P receive FDA 510(k) clearance?

FI-10P received FDA 510(k) clearance on 1995-04-06, under 510(k) number K951195.

Who is the listed applicant for FI-10P?

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 FI-10P?

The FDA product code for FI-10P is CAL.

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: CAL)

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.

K951194FI-10MPentax Precision Instrument Corp.K872895HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.Haemonetics Corp.K852994REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11Reichert-Jung, Inc.K850978OLYMPUS LF-1 INTUBATION SCOPEOlympus Corp.K802331AO FLEXIBLE LARYNGOSCOPE, #LS-7American Optical Corp.K801364AO STYLET LARYNGOSCOPE MODEL SLSAmerican Optical Corp.

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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