FDA 510(k)

OPAP

K-Number: K991926 · 1999-10-18

Decision Date1999-10-18

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

OPAP is the device name listed in this FDA 510(k) record. The listed applicant is Opap, Inc.. It received FDA 510(k) clearance on 1999-10-18 under 510(k) number K991926. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPAP?

OPAP is a medical device that received FDA 510(k) clearance on 1999-10-18. The listed applicant is Opap, Inc.. The 510(k) number is K991926.

When did OPAP receive FDA 510(k) clearance?

OPAP received FDA 510(k) clearance on 1999-10-18, under 510(k) number K991926.

Who is the listed applicant for OPAP?

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

What is the FDA product code for OPAP?

The FDA product code for OPAP is BZD.

Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed Corp K254104ResScan EssentialsResmed Corp K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

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.