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FDA 510(k)

LIFESENSE, MODEL LS1-9R

K-Number: K063752 · 2007-05-04

ApplicantNonin Medical, Inc.
Decision Date2007-05-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFESENSE, MODEL LS1-9R is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2007-05-04 under 510(k) number K063752. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESENSE, MODEL LS1-9R?

LIFESENSE, MODEL LS1-9R is a medical device that received FDA 510(k) clearance on 2007-05-04. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K063752.

When did LIFESENSE, MODEL LS1-9R receive FDA 510(k) clearance?

LIFESENSE, MODEL LS1-9R received FDA 510(k) clearance on 2007-05-04, under 510(k) number K063752.

Who is the listed applicant for LIFESENSE, MODEL LS1-9R?

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

What is the FDA product code for LIFESENSE, MODEL LS1-9R?

The FDA product code for LIFESENSE, MODEL LS1-9R is DQA.

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Related Devices (Code: DQA)

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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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