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FDA 510(k)

SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE

K-Number: K052947 · 2006-04-19

ApplicantSource Production & Equipment Co., Inc.
Decision Date2006-04-19
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE is the device name listed in this FDA 510(k) record. The listed applicant is Source Production & Equipment Co., Inc.. It received FDA 510(k) clearance on 2006-04-19 under 510(k) number K052947. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE?

SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE is a medical device that received FDA 510(k) clearance on 2006-04-19. The listed applicant is Source Production & Equipment Co., Inc.. The 510(k) number is K052947.

When did SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE receive FDA 510(k) clearance?

SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE received FDA 510(k) clearance on 2006-04-19, under 510(k) number K052947.

Who is the listed applicant for SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE?

The FDA 510(k) record lists Source Production & Equipment Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE?

The FDA product code for SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BRACHYTHERAPY SOURCE is JAQ.

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Other records listing Source Production & Equipment Co., Inc. 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.

K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceK161396SPEC Model M23K161395SPEC Model M13K090366SPEC MODEL M-31

Related Devices (Code: JAQ)

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.

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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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