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FDA 510(k)

SPUR ADULT WITH OPEN RESERVOIR SYSTEM

K-Number: K922707 · 1992-06-19

ApplicantAmbu, Inc.
Decision Date1992-06-19
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPUR ADULT WITH OPEN RESERVOIR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ambu, Inc.. It received FDA 510(k) clearance on 1992-06-19 under 510(k) number K922707. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPUR ADULT WITH OPEN RESERVOIR SYSTEM?

SPUR ADULT WITH OPEN RESERVOIR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-19. The listed applicant is Ambu, Inc.. The 510(k) number is K922707.

When did SPUR ADULT WITH OPEN RESERVOIR SYSTEM receive FDA 510(k) clearance?

SPUR ADULT WITH OPEN RESERVOIR SYSTEM received FDA 510(k) clearance on 1992-06-19, under 510(k) number K922707.

Who is the listed applicant for SPUR ADULT WITH OPEN RESERVOIR SYSTEM?

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

What is the FDA product code for SPUR ADULT WITH OPEN RESERVOIR SYSTEM?

The FDA product code for SPUR ADULT WITH OPEN RESERVOIR SYSTEM is BTM.

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Other records listing Ambu, 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.

K051529AMBU NEUROLINE GROUNDK042682AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATORK042843AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORSK041734AMBU DISPOSABLE ECG ELECTRODEK040991AMBU DISPOSABLE PRESSURE MANOMETERK041026AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

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Related Devices (Code: BTM)

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.

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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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