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FDA 510(k)

RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR

K-Number: K892885 · 1989-10-06

ApplicantFisher & Paykel Electronics , Ltd.
Decision Date1989-10-06
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Electronics , Ltd.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K892885. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR?

RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Fisher & Paykel Electronics , Ltd.. The 510(k) number is K892885.

When did RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR receive FDA 510(k) clearance?

RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR received FDA 510(k) clearance on 1989-10-06, under 510(k) number K892885.

Who is the listed applicant for RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR?

The FDA 510(k) record lists Fisher & Paykel Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR?

The FDA product code for RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR is BTL.

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Other records listing Fisher & Paykel Electronics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K973161CPAP HUMIDIFIER (HC 200)K972885SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970K971695SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMERK971461SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)K970432INFANT RADIANT WARMER - MODELS IW910 AND IW920K953392HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)

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Related Devices (Code: BTL)

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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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