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FDA 510(k)

JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009

K-Number: K970035 · 1997-04-01

ApplicantGraham-Field, Inc.
Decision Date1997-04-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 is the device name listed in this FDA 510(k) record. The listed applicant is Graham-Field, Inc.. It received FDA 510(k) clearance on 1997-04-01 under 510(k) number K970035. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 is a medical device that received FDA 510(k) clearance on 1997-04-01. The listed applicant is Graham-Field, Inc.. The 510(k) number is K970035.

When did JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 receive FDA 510(k) clearance?

JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 received FDA 510(k) clearance on 1997-04-01, under 510(k) number K970035.

Who is the listed applicant for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

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

What is the FDA product code for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009?

The FDA product code for JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 is CAF.

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Related Devices (Code: CAF)

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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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