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FDA 510(k)

SHOULDER RETRACTOR

K-Number: K944613 · 1995-01-18

ApplicantNorthwest Medical Physics Center
Decision Date1995-01-18
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SHOULDER RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Northwest Medical Physics Center. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K944613. 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 SHOULDER RETRACTOR?

SHOULDER RETRACTOR is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is Northwest Medical Physics Center. The 510(k) number is K944613.

When did SHOULDER RETRACTOR receive FDA 510(k) clearance?

SHOULDER RETRACTOR received FDA 510(k) clearance on 1995-01-18, under 510(k) number K944613.

Who is the listed applicant for SHOULDER RETRACTOR?

The FDA 510(k) record lists Northwest Medical Physics Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOULDER RETRACTOR?

The FDA product code for SHOULDER RETRACTOR is KPR.

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Other records listing Northwest Medical Physics Center 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.

K953227CASPERK941118HEAD IMMOBILIZATION APPARATUSK933117IORT SYSTEMK930182RADIATION TREATMENT FOR CANCER PATIENTSK904908STEREOTACTIC IRRADIATION SYSTEM

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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