MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

Chamber, Hyperbaric

HYPERTEC, INC.

The following data is part of a premarket notification filed by Hypertec, Inc. with the FDA for Model 5000 Multiplace Hyperbaric Therapy.

Pre-market Notification Details

• Device ID: K002794
• 510k Number: K002794
• Device Name: MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
• Classification: Chamber, Hyperbaric
• Applicant: HYPERTEC, INC. PO BOX 7007 Deerfield, IL 60015
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; HYPERTEC, INC. PO BOX 7007 Deerfield, IL 60015
• Product Code: CBF
• CFR Regulation Number: 868.5470 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-07
• Decision Date: 2000-12-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08906124940005	K002794	000