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FDA 510(k)

INFANT NASAL CANNULAE ASSEMBLY, MODIFIED

K-Number: K911780 · 1991-06-24

ApplicantAckrad Laboratories
Decision Date1991-06-24
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFANT NASAL CANNULAE ASSEMBLY, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1991-06-24 under 510(k) number K911780. 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 INFANT NASAL CANNULAE ASSEMBLY, MODIFIED?

INFANT NASAL CANNULAE ASSEMBLY, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-06-24. The listed applicant is Ackrad Laboratories. The 510(k) number is K911780.

When did INFANT NASAL CANNULAE ASSEMBLY, MODIFIED receive FDA 510(k) clearance?

INFANT NASAL CANNULAE ASSEMBLY, MODIFIED received FDA 510(k) clearance on 1991-06-24, under 510(k) number K911780.

Who is the listed applicant for INFANT NASAL CANNULAE ASSEMBLY, MODIFIED?

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

What is the FDA product code for INFANT NASAL CANNULAE ASSEMBLY, MODIFIED?

The FDA product code for INFANT NASAL CANNULAE ASSEMBLY, MODIFIED is BZD.

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Other records listing Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET

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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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