FDA 510(k)

OLV 1100; OLV 1200 PULSE OXIMETERS

K-Number: K881307 · 1988-11-04

Decision Date1988-11-04

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OLV 1100; OLV 1200 PULSE OXIMETERS is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K881307. 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 OLV 1100; OLV 1200 PULSE OXIMETERS?

OLV 1100; OLV 1200 PULSE OXIMETERS is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K881307.

When did OLV 1100; OLV 1200 PULSE OXIMETERS receive FDA 510(k) clearance?

OLV 1100; OLV 1200 PULSE OXIMETERS received FDA 510(k) clearance on 1988-11-04, under 510(k) number K881307.

Who is the listed applicant for OLV 1100; OLV 1200 PULSE OXIMETERS?

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

What is the FDA product code for OLV 1100; OLV 1200 PULSE OXIMETERS?

The FDA product code for OLV 1100; OLV 1200 PULSE OXIMETERS is DQA.

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Other records listing Nihon Kohden America, Inc. as applicant

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Related Devices (Code: DQA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.