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FDA 510(k)

VELOS CONSTANCY CHECK DEVICE, MODEL 55-145

K-Number: K970384 · 1997-07-29

ApplicantAktina Medical Physics Corp.
Decision Date1997-07-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Physics Corp.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K970384. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VELOS CONSTANCY CHECK DEVICE, MODEL 55-145?

VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Aktina Medical Physics Corp.. The 510(k) number is K970384.

When did VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 receive FDA 510(k) clearance?

VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 received FDA 510(k) clearance on 1997-07-29, under 510(k) number K970384.

Who is the listed applicant for VELOS CONSTANCY CHECK DEVICE, MODEL 55-145?

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

What is the FDA product code for VELOS CONSTANCY CHECK DEVICE, MODEL 55-145?

The FDA product code for VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 is IYE.

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Other records listing Aktina Medical Physics Corp. as applicant

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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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