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FDA 510(k)

AUGUSTINE FIBEROPTIC LARYNGOSCOPE

K-Number: K915161 · 1992-05-29

ApplicantAugustine Medical, Inc.
Decision Date1992-05-29
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUGUSTINE FIBEROPTIC LARYNGOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Medical, Inc.. It received FDA 510(k) clearance on 1992-05-29 under 510(k) number K915161. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUGUSTINE FIBEROPTIC LARYNGOSCOPE?

AUGUSTINE FIBEROPTIC LARYNGOSCOPE is a medical device that received FDA 510(k) clearance on 1992-05-29. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K915161.

When did AUGUSTINE FIBEROPTIC LARYNGOSCOPE receive FDA 510(k) clearance?

AUGUSTINE FIBEROPTIC LARYNGOSCOPE received FDA 510(k) clearance on 1992-05-29, under 510(k) number K915161.

Who is the listed applicant for AUGUSTINE FIBEROPTIC LARYNGOSCOPE?

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

What is the FDA product code for AUGUSTINE FIBEROPTIC LARYNGOSCOPE?

The FDA product code for AUGUSTINE FIBEROPTIC LARYNGOSCOPE is CCW.

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Other records listing Augustine Medical, 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.

K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMK020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXK001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANKK973741BAIR HUGGER BLOOD/FLUID WARMERK964673BAIR HUGGER MODEL 630 CARDIAC BLANKETK963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

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Related Devices (Code: CCW)

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.

K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLCK121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETNovamed, LLCK062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, 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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