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FDA 510(k)

BREEZE DIGITAL INFLATION DEVICE

K-Number: K953676 · 1996-03-29

ApplicantNamic
Decision Date1996-03-29
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BREEZE DIGITAL INFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Namic. It received FDA 510(k) clearance on 1996-03-29 under 510(k) number K953676. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREEZE DIGITAL INFLATION DEVICE?

BREEZE DIGITAL INFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1996-03-29. The listed applicant is Namic. The 510(k) number is K953676.

When did BREEZE DIGITAL INFLATION DEVICE receive FDA 510(k) clearance?

BREEZE DIGITAL INFLATION DEVICE received FDA 510(k) clearance on 1996-03-29, under 510(k) number K953676.

Who is the listed applicant for BREEZE DIGITAL INFLATION DEVICE?

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

What is the FDA product code for BREEZE DIGITAL INFLATION DEVICE?

The FDA product code for BREEZE DIGITAL INFLATION DEVICE is MAV.

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Other records listing Namic 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.

K951722PERCEPTOR COMPENSATOR MORSE MANIFOLDK921322MORSE ANESTHESIA MANIFOLDK822100HIGH PRESSURE CONTRAST INJECTION LINEK813549CONTINUOUS FLUSH DEVICEK790082ARTERIAL EXTENSION SETK790083CATHETER, ARTERIAL LINE

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Related Devices (Code: MAV)

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.

K260035Digital Indeflator INFLANTEUAB TelemedicinaK220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic VascularK162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.K130566BASIXTOUCHMerit Medical Systems, 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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