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FDA 510(k)

WHITMORE ANKLE X-RAY EXTENSION (AXE)

K-Number: K933778 · 1993-12-13

ApplicantWhitmore Ent., Inc.
Decision Date1993-12-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

WHITMORE ANKLE X-RAY EXTENSION (AXE) is the device name listed in this FDA 510(k) record. The listed applicant is Whitmore Ent., Inc.. It received FDA 510(k) clearance on 1993-12-13 under 510(k) number K933778. 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 WHITMORE ANKLE X-RAY EXTENSION (AXE)?

WHITMORE ANKLE X-RAY EXTENSION (AXE) is a medical device that received FDA 510(k) clearance on 1993-12-13. The listed applicant is Whitmore Ent., Inc.. The 510(k) number is K933778.

When did WHITMORE ANKLE X-RAY EXTENSION (AXE) receive FDA 510(k) clearance?

WHITMORE ANKLE X-RAY EXTENSION (AXE) received FDA 510(k) clearance on 1993-12-13, under 510(k) number K933778.

Who is the listed applicant for WHITMORE ANKLE X-RAY EXTENSION (AXE)?

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

What is the FDA product code for WHITMORE ANKLE X-RAY EXTENSION (AXE)?

The FDA product code for WHITMORE ANKLE X-RAY EXTENSION (AXE) 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 Whitmore Ent., 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.

K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)

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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