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FDA 510(k)

NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)

K-Number: K911399 · 1991-09-19

ApplicantAequitron Medical, Inc.
Decision Date1991-09-19
Product CodeDZD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) is the device name listed in this FDA 510(k) record. The listed applicant is Aequitron Medical, Inc.. It received FDA 510(k) clearance on 1991-09-19 under 510(k) number K911399. The device is classified under product code DZD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)?

NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) is a medical device that received FDA 510(k) clearance on 1991-09-19. The listed applicant is Aequitron Medical, Inc.. The 510(k) number is K911399.

When did NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) receive FDA 510(k) clearance?

NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) received FDA 510(k) clearance on 1991-09-19, under 510(k) number K911399.

Who is the listed applicant for NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)?

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

What is the FDA product code for NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)?

The FDA product code for NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) is DZD.

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Other records listing Aequitron Medical, Inc. as applicant

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Related Devices (Code: DZD)

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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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