EMS NASAL CPAP MASK

Ventilator, Non-continuous (respirator)

ENGINEERED MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Nasal Cpap Mask.

Pre-market Notification Details

• Device ID: K972605
• 510k Number: K972605
• Device Name: EMS NASAL CPAP MASK
• Classification: Ventilator, Non-continuous (respirator)
• Applicant: ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268
• Contact: Bonnie Holly
• Correspondent: Bonnie Holly; ENGINEERED MEDICAL SYSTEMS 8529 ZIONSVILLE RD. P.O. BOX 681514 Indianapolis, IN 46268
• Product Code: BZD
• CFR Regulation Number: 868.5905 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-11
• Decision Date: 1998-01-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10841470105508	K972605	000
10841470107007	K972605	000
10841470107083	K972605	000
10841470107090	K972605	000
10841470107106	K972605	000
10841470107588	K972605	000
10841470107595	K972605	000
10841470107601	K972605	000
10841470107618	K972605	000
10841470107625	K972605	000
10841470107632	K972605	000
10841470106826	K972605	000
10841470106727	K972605	000
10841470105515	K972605	000
10841470105522	K972605	000
10841470105539	K972605	000
10841470106444	K972605	000
10841470106451	K972605	000
10841470106468	K972605	000
10841470106475	K972605	000
10841470106482	K972605	000
10841470106567	K972605	000
10841470106710	K972605	000
10841470107649	K972605	000
10841470107663	K972605	000
10841470107717	K972605	000
10841470107977	K972605	000
10841470111295	K972605	000
10841470111301	K972605	000
10841470111318	K972605	000
10841470111325	K972605	000
10841470111332	K972605	000
10841470111349	K972605	000
10841470111356	K972605	000
10841470111363	K972605	000
10841470107885	K972605	000
10841470107960	K972605	000
10841470107946	K972605	000
10841470107724	K972605	000
10841470107731	K972605	000
10841470107809	K972605	000
10841470107816	K972605	000
10841470107823	K972605	000
10841470107830	K972605	000
10841470107892	K972605	000
10841470107908	K972605	000
10841470107915	K972605	000
10841470107939	K972605	000
10841470109353	K972605	000