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FDA 510(k)

OPERATIVE RECORDING CAMERA

K-Number: K904113 · 1990-10-30

ApplicantMedical Dynamics, Inc.
Decision Date1990-10-30
Product CodeIKO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OPERATIVE RECORDING CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Medical Dynamics, Inc.. It received FDA 510(k) clearance on 1990-10-30 under 510(k) number K904113. The device is classified under product code IKO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERATIVE RECORDING CAMERA?

OPERATIVE RECORDING CAMERA is a medical device that received FDA 510(k) clearance on 1990-10-30. The listed applicant is Medical Dynamics, Inc.. The 510(k) number is K904113.

When did OPERATIVE RECORDING CAMERA receive FDA 510(k) clearance?

OPERATIVE RECORDING CAMERA received FDA 510(k) clearance on 1990-10-30, under 510(k) number K904113.

Who is the listed applicant for OPERATIVE RECORDING CAMERA?

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

What is the FDA product code for OPERATIVE RECORDING CAMERA?

The FDA product code for OPERATIVE RECORDING CAMERA is IKO.

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Other records listing Medical Dynamics, 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.

K974542TRUE VISION, TRUE VISION IIK921294VIDEO ENDOSCOPE-RIGID MODIFICATIONK934682SURGICAL VIDEO CAMERA AND ACCESSORIESK930568ADAIR/VERESS NEEDLE INTRODUCER SETK915538OVER THE WIRE STONE BASKETK914315OPTICAL CATHETER INTRODUCER SETS, MODIFICATION

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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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