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FDA 510(k)

AIR-PWOERED COLDRILL

K-Number: K780646 · 1978-04-28

ApplicantMedishield, Inc.
Decision Date1978-04-28
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIR-PWOERED COLDRILL is the device name listed in this FDA 510(k) record. The listed applicant is Medishield, Inc.. It received FDA 510(k) clearance on 1978-04-28 under 510(k) number K780646. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR-PWOERED COLDRILL?

AIR-PWOERED COLDRILL is a medical device that received FDA 510(k) clearance on 1978-04-28. The listed applicant is Medishield, Inc.. The 510(k) number is K780646.

When did AIR-PWOERED COLDRILL receive FDA 510(k) clearance?

AIR-PWOERED COLDRILL received FDA 510(k) clearance on 1978-04-28, under 510(k) number K780646.

Who is the listed applicant for AIR-PWOERED COLDRILL?

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

What is the FDA product code for AIR-PWOERED COLDRILL?

The FDA product code for AIR-PWOERED COLDRILL is EKX.

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Other records listing Medishield, 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.

K781103SPECTRASCANK780645HMD-2000 BATTERY-POWERED MINI-DRILL, THEK780202MONOMER EVACUATION SYSTEMK770161MICROFENESTRATED HIP REPLACEMENT COMPON.K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)K761020ANKLE (FREEMAN-SWANSON)

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Related Devices (Code: EKX)

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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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