Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPEC Model M13

K-Number: K161395 · 2016-07-06

ApplicantSource Production and Equipment Co., Inc.
Decision Date2016-07-06
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPEC Model M13 is the device name listed in this FDA 510(k) record. The listed applicant is Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K161395. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEC Model M13?

SPEC Model M13 is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Source Production and Equipment Co., Inc.. The 510(k) number is K161395.

When did SPEC Model M13 receive FDA 510(k) clearance?

SPEC Model M13 received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161395.

Who is the listed applicant for SPEC Model M13?

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

What is the FDA product code for SPEC Model M13?

The FDA product code for SPEC Model M13 is KXK.

Other records listing Source Production and 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 M23

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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.

↑