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FDA 510(k)

PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER

K-Number: K935580 · 1994-03-16

ApplicantPrecise Optics
Decision Date1994-03-16
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K935580. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER?

PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Precise Optics. The 510(k) number is K935580.

When did PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER receive FDA 510(k) clearance?

PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER received FDA 510(k) clearance on 1994-03-16, under 510(k) number K935580.

Who is the listed applicant for PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER?

The FDA 510(k) record lists Precise Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER?

The FDA product code for PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER is OXO.

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Other records listing Precise Optics 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.

K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMK932878PRECISION INTRA-ORAL SCOPESK914084ENDOSCOPESK914184P2020-8-0 BEAM-LIMITING DEVICEK911744PRECISION OPTICS CORPORATION LAPAROSCOPEK903459PRECISION OPTICS ENDOSCOPE ADAPTER

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Related Devices (Code: OXO)

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.

K253296Digital C-ARM with 3DAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, 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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