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FDA 510(k)

BREMER IMAGING TONGS-MRI MODEL

K-Number: K924606 · 1993-09-09

ApplicantBremer Medical, Inc.
Decision Date1993-09-09
Product CodeHAX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BREMER IMAGING TONGS-MRI MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Bremer Medical, Inc.. It received FDA 510(k) clearance on 1993-09-09 under 510(k) number K924606. The device is classified under product code HAX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREMER IMAGING TONGS-MRI MODEL?

BREMER IMAGING TONGS-MRI MODEL is a medical device that received FDA 510(k) clearance on 1993-09-09. The listed applicant is Bremer Medical, Inc.. The 510(k) number is K924606.

When did BREMER IMAGING TONGS-MRI MODEL receive FDA 510(k) clearance?

BREMER IMAGING TONGS-MRI MODEL received FDA 510(k) clearance on 1993-09-09, under 510(k) number K924606.

Who is the listed applicant for BREMER IMAGING TONGS-MRI MODEL?

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

What is the FDA product code for BREMER IMAGING TONGS-MRI MODEL?

The FDA product code for BREMER IMAGING TONGS-MRI MODEL is HAX.

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Other records listing Bremer Medical, 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.

K915800BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN

Related Devices (Code: HAX)

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.

K090733PMT HALO SYSTEMPmt Corp.K071173RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)K051918RESOLVE OPEN BACK HALO RINGSJerome MedicalK023959JEROME GLASS RINGThe Jerome Group, Inc.K003662SPINE WORKS COLLARSpine WorksK980689FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEMFriddle'S Orthopedic Appliances, 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.

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