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FDA 510(k)

RESPIRADYNE II(TM)

K-Number: K863866 · 1987-01-28

ApplicantChesebrough-Pond'S U.S.A. Co.
Decision Date1987-01-28
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRADYNE II(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Chesebrough-Pond'S U.S.A. Co.. It received FDA 510(k) clearance on 1987-01-28 under 510(k) number K863866. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRADYNE II(TM)?

RESPIRADYNE II(TM) is a medical device that received FDA 510(k) clearance on 1987-01-28. The listed applicant is Chesebrough-Pond'S U.S.A. Co.. The 510(k) number is K863866.

When did RESPIRADYNE II(TM) receive FDA 510(k) clearance?

RESPIRADYNE II(TM) received FDA 510(k) clearance on 1987-01-28, under 510(k) number K863866.

Who is the listed applicant for RESPIRADYNE II(TM)?

The FDA 510(k) record lists Chesebrough-Pond'S U.S.A. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRADYNE II(TM)?

The FDA product code for RESPIRADYNE II(TM) is BZK.

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Other records listing Chesebrough-Pond'S U.S.A. Co. 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.

K862803CHESEBROUGH POND'S HYDROCOLLOID DRESSINGK851382CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSINGK851383BLISTERFILM TRANSPARENT DRESSINGK851539CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLOK843567KANGAROO NASOGASTRIC FEEDING TUBEK845010CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH

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Related Devices (Code: BZK)

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.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, Inc.

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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