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FDA 510(k)

OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM

K-Number: K011549 · 2001-07-19

ApplicantOhmeda Medical
Decision Date2001-07-19
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 2001-07-19 under 510(k) number K011549. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM?

OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2001-07-19. The listed applicant is Ohmeda Medical. The 510(k) number is K011549.

When did OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM receive FDA 510(k) clearance?

OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM received FDA 510(k) clearance on 2001-07-19, under 510(k) number K011549.

Who is the listed applicant for OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM?

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

What is the FDA product code for OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM?

The FDA product code for OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM is LBI.

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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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