HELIO2 BLENDER

Mixer, Breathing Gases, Anesthesia Inhalation

PRECISION MEDICAL, INC.

The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Helio2 Blender.

Pre-market Notification Details

• Device ID: K090781
• 510k Number: K090781
• Device Name: HELIO2 BLENDER
• Classification: Mixer, Breathing Gases, Anesthesia Inhalation
• Applicant: PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067
• Contact: James Parker
• Correspondent: James Parker; PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067
• Product Code: BZR
• CFR Regulation Number: 868.5330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-23
• Decision Date: 2009-08-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855887006054	K090781	000
00855887006047	K090781	000
00855887006030	K090781	000
00855887006023	K090781	000