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FDA 510(k)

SINGUL-XR RP NON SCREEN MED. FILM

K-Number: K834611 · 1984-02-21

ApplicantCea America Corp.
Decision Date1984-02-21
Product CodeIWZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SINGUL-XR RP NON SCREEN MED. FILM is the device name listed in this FDA 510(k) record. The listed applicant is Cea America Corp.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834611. The device is classified under product code IWZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGUL-XR RP NON SCREEN MED. FILM?

SINGUL-XR RP NON SCREEN MED. FILM is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Cea America Corp.. The 510(k) number is K834611.

When did SINGUL-XR RP NON SCREEN MED. FILM receive FDA 510(k) clearance?

SINGUL-XR RP NON SCREEN MED. FILM received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834611.

Who is the listed applicant for SINGUL-XR RP NON SCREEN MED. FILM?

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

What is the FDA product code for SINGUL-XR RP NON SCREEN MED. FILM?

The FDA product code for SINGUL-XR RP NON SCREEN MED. FILM is IWZ.

Related Clinical Trials

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Other records listing Cea America 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.

K942525MEDICOUNT DEKA HEMATOLOGY ANALYZERK834614WILCOR-XR RP-L MEDICAL FILMK834613WILCOR-XR RP MEDICAL FILMK834612WILCOR-XR RP-OG MEDICAL FILM

Related Devices (Code: IWZ)

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.

K970154KODAK EKTASIAN HG FILM (EHG-15)Eastman Kodak CompanyK954200VOXGRAMVoxelK9316043M MEDICAL DIAGNOSTIC VIDEOCASSETTE3M Health Care, Ltd.K9316053M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE3M Health Care, Ltd.K920539ORWO X-RAY FILMBurkhart Roentgen Intl., Inc.K884827KODAK DENTAL BARRIER PACEastman Kodak Company

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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