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FDA 510(k)

SR SUITE 1.0

K-Number: K121345 · 2012-06-01

ApplicantHalifax Biomedical, Inc.
Decision Date2012-06-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SR SUITE 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Halifax Biomedical, Inc.. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K121345. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SR SUITE 1.0?

SR SUITE 1.0 is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Halifax Biomedical, Inc.. The 510(k) number is K121345.

When did SR SUITE 1.0 receive FDA 510(k) clearance?

SR SUITE 1.0 received FDA 510(k) clearance on 2012-06-01, under 510(k) number K121345.

Who is the listed applicant for SR SUITE 1.0?

The FDA 510(k) record lists Halifax Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR SUITE 1.0?

The FDA product code for SR SUITE 1.0 is KPR.

Related Clinical Trials

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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Other records listing Halifax Biomedical, 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.

K182880Halifax Imaging KitK103417HALIFAX BIOMEDICAL TANATLUM BEAD SETK090581TANTALUM BEAD SET, MODEL P003175

Related Devices (Code: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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