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FDA 510(k)

NASAL/ORAL MASK

K-Number: K925587 · 1993-09-14

ApplicantRespironics, Inc.
Decision Date1993-09-14
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NASAL/ORAL MASK is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 1993-09-14 under 510(k) number K925587. 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 NASAL/ORAL MASK?

NASAL/ORAL MASK is a medical device that received FDA 510(k) clearance on 1993-09-14. The listed applicant is Respironics, Inc.. The 510(k) number is K925587.

When did NASAL/ORAL MASK receive FDA 510(k) clearance?

NASAL/ORAL MASK received FDA 510(k) clearance on 1993-09-14, under 510(k) number K925587.

Who is the listed applicant for NASAL/ORAL MASK?

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

What is the FDA product code for NASAL/ORAL MASK?

The FDA product code for NASAL/ORAL MASK is BZD.

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Other records listing Respironics, Inc. 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.

K261262Altis Full Face MaskK243394AF531 Oro-Nasal SE Face MaskK231313Therapy Mask 3100 NC/SPK210844DreamWear Silicone Pillows MaskK210386Magneto Nasal MaskK202142Sleepware G3

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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 CorpK254104ResScan EssentialsResmed CorpK251920Sleep 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

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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