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FDA 510(k)

BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION

K-Number: K010691 · 2001-05-08

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date2001-05-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 2001-05-08 under 510(k) number K010691. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION?

BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION is a medical device that received FDA 510(k) clearance on 2001-05-08. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K010691.

When did BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION receive FDA 510(k) clearance?

BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION received FDA 510(k) clearance on 2001-05-08, under 510(k) number K010691.

Who is the listed applicant for BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION?

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

What is the FDA product code for BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION?

The FDA product code for BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION is LNH.

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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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