FDA 510(k)

NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)

K-Number: K963707 · 1996-12-13

Decision Date1996-12-13

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) is the device name listed in this FDA 510(k) record. The listed applicant is Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 1996-12-13 under 510(k) number K963707. 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 NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)?

NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) is a medical device that received FDA 510(k) clearance on 1996-12-13. The listed applicant is Nellcor Puritan Bennett, Inc.. The 510(k) number is K963707.

When did NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) receive FDA 510(k) clearance?

NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) received FDA 510(k) clearance on 1996-12-13, under 510(k) number K963707.

Who is the listed applicant for NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)?

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

What is the FDA product code for NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)?

The FDA product code for NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) is DQA.

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Other records listing Nellcor Puritan Bennett, Inc. as applicant

K070408DURAMAX REUSABLE OXIMETRY SENSOR K060576NELLCOR OXIMAX N-600X PULSE OXIMETER K051271OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR K052186NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P K051352OXIMAX NPB-40 HANDHELD PULSE OXIMETER K050072GOODKNIGHT 425ST

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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.