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 a medical device manufactured by Source Production and Equipment Co., Inc.. It received FDA 510(k) clearance on 2016-07-06 under approval 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. It is manufactured by Source Production and Equipment Co., Inc.. The 510(k) number is K161395.

When was SPEC Model M13 approved by the FDA?

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

What company makes SPEC Model M13?

SPEC Model M13 is manufactured by Source Production and Equipment Co., Inc..

What is the FDA product code for SPEC Model M13?

The FDA product code for SPEC Model M13 is KXK.

Other Devices by Source Production and Equipment Co., Inc.

K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source K161396SPEC Model M23

Related Devices (Code: KXK)

K163206SMD-Sr90-DA Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc. K162573Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy SourceSource Production and Equipment Co., Inc. K161396SPEC Model M23Source Production and Equipment Co., Inc. K171487Sirius MRI Marker NSC4 Imaging, LLC K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp. K180515GammaTileIsoray Medical, 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.