MERCURY AIRWAY PRESSURE MANOMETER

K954486 · Mercury Medical · CAP · Apr 25, 1996 · Anesthesiology

Device Facts

• Record ID: K954486
• Device Name: MERCURY AIRWAY PRESSURE MANOMETER
• Applicant: Mercury Medical
• Product Code: CAP · Anesthesiology
• Decision Date: Apr 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2

Intended Use

The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H₂O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure.

Device Story

Disposable airway pressure manometer; measures pressure up to 80 cm H₂O; connects via flexible tubing to Mercury CPR bag or similar ventilation devices; used in clinical settings by healthcare providers; provides real-time pressure monitoring to assist in manual ventilation; ensures airway pressure remains within safe limits during resuscitation or respiratory support.

Clinical Evidence

Bench testing only; device performance compared to predicate gauge.

Technological Characteristics

Disposable manometer; pressure range 0-80 cm H₂O; flexible tubing interface; mechanical gauge design.

Indications for Use

Indicated for monitoring airway pressure up to 80 cm H₂O in patients requiring manual ventilation via CPR bags or similar devices providing expiratory pressure.

Regulatory Classification

Identification

An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Predicate Devices

• Dwyer Magnahelic Gauge (pre-amendment)

Submission Summary (Full Text)

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MERCURY MEDICAL®
K954486

# ENCLOSURE I

## 510(k) SUMMARY

- Mercury Airway Pressure Manometer
- Airway Pressure Manometer (gauge)
- monitor, airway pressure (includes gauge)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21CFR 807.92.

The Mercury Airway Pressure Manometer is a disposable manometer intended to measure airway pressure up to 80 cm H₂O. It is designed to be attached by flexible tubing to the Mercury CPR bag or other devices providing expiratory pressure. Bench testing has determined that the Mercury Airway Pressure Manometer measures airway pressures up to 80 cm H₂O in a manner consistent with the Dwyer Magnahelic Gauge, a pre-amendment device.

Kathy L. Hann

9/22/95
Date

11300 49th Street North • Clearwater, Florida 34622-4800 • 813-573-0088