Singul-Xr RP Non Screen Med. Film

FDA 510(k) K834611 · Cea America Corp.

Substantially Equivalent

510(k) numberK834611

Submission

Device name
Singul-Xr RP Non Screen Med. Film
Applicant
Cea America Corp.
Mchenry, IL, US
Received
December 20, 1983
Decision date
February 21, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IWZ – Film, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1840
Specialty
Radiology

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K862944Kodak CFT Film SO-141IWZ · Traditional Eastman Kodak Company08/12/1986SE
K862415Type 633 Computed Radiography (CR) FilmIWZ · Traditional Parexel Intl. Corp.07/01/1986SE
K860797Medical X-Ray FilmIWZ · Traditional India-America Trading Co.03/13/1986SE
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More from Belmont Equipment Corp.

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K942525Medicount Deka Hematology AnalyzerGKZ · Traditional 06/05/1996SE
K834614Wilcor-Xr Rp-L Medical FilmIWZ · Traditional 03/05/1984SE
K834613Wilcor-Xr RP Medical FilmIWZ · Traditional 03/05/1984SE
K834612Wilcor-Xr Rp-Og Medical FilmIWZ · Traditional 02/27/1984SE

Questions and answers

When was Singul-Xr RP Non Screen Med. Film cleared by the FDA?

Singul-Xr RP Non Screen Med. Film (K834611) received a 510(k) decision of Substantially Equivalent on February 21, 1984, 63 days after the submission was received.

What is the product code of K834611?

The FDA product code is IWZ – Film, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1840.