BAXTER NEBULIZER CAP MODEL 2D0868

K962161 · Baxter Healthcare Corp · CAF · Aug 15, 1996 · Anesthesiology

Device Facts

• Record ID: K962161
• Device Name: BAXTER NEBULIZER CAP MODEL 2D0868
• Applicant: Baxter Healthcare Corp
• Product Code: CAF · Anesthesiology
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Baxter Healthcare Corporation's Nebulizer Cap is for use with Sterile Water for Inhalation, USP, in 500 ml, 1000 ml, and 1500 ml plastic bottles, for inhalation therapy only.

Device Story

Nebulizer cap designed for attachment to sterile water bottles for inhalation therapy. Device functions as interface between water source and nebulization equipment. Operation involves mechanical connection to standard plastic bottles. Used in clinical or home settings by patients or caregivers. Output is controlled delivery of sterile water for inhalation. Benefit includes facilitating respiratory therapy delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nebulizer cap; materials include aluminum alloy with specific coating; dimensions and specifications identical to predicate device.

Indications for Use

Indicated for patients requiring inhalation therapy using Sterile Water for Inhalation, USP, delivered via 500 ml, 1000 ml, or 1500 ml plastic bottles.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Baxter Healthcare Corporation (K780406)

Submission Summary (Full Text)

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AUG 15 1996

510(K) SUMMARY
(as required by 807.92(c))

K 962161

Submitter of 510(k):
Tamima Itani, Ph.D.
Baxter Healthcare Corp.
I.V. Systems Division
Route 120 & Wilson Rd.
Round Lake, IL 60073

Regulatory & Marketing Services, Inc. (RMS)
40178 U.S. 19 North
Tarpon Springs, FL 34689

Phone: [phone]
Fax: [phone]

Contact Person:
Ed Ransom

Date of Summary:
04/26/96

Trade Name:
Baxter Nebulizer Cap

Classification Name:
Nebulizer Cap

Predicate Device:
Baxter Healthcare Corporation K780406

Device Description/Comparison:
All blueprints dimension and specifications are exactly the same in this device as found in the predicate device. The only change is the aluminum alloy and the coating. The rest of the device remains the same as currently marketed.

Intended Use:
The Baxter Healthcare Corporation's Nebulizer Cap is for use with Sterile Water for Inhalation, USP, in 500 ml, 1000 ml, and 1500 ml plastic bottles, for inhalation therapy only.

MAY 30 1996
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