BABYPAC

Ventilator, Continuous, Facility Use

PNEUPAC, INC.

The following data is part of a premarket notification filed by Pneupac, Inc. with the FDA for Babypac.

Pre-market Notification Details

• Device ID: K970158
• 510k Number: K970158
• Device Name: BABYPAC
• Classification: Ventilator, Continuous, Facility Use
• Applicant: PNEUPAC, INC. P.O. BOX 973 Wake Forest, NC 27588
• Contact: Norman Gray
• Correspondent: Norman Gray; PNEUPAC, INC. P.O. BOX 973 Wake Forest, NC 27588
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-16
• Decision Date: 1998-04-28

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30610586045749	K970158	000
30610586038284	K970158	000