MAXITHERM

System, Thermal Regulating

CINCINNATI SUB-ZERO

The following data is part of a premarket notification filed by Cincinnati Sub-zero with the FDA for Maxitherm.

Pre-market Notification Details

• Device ID: K811743
• 510k Number: K811743
• Device Name: MAXITHERM
• Classification: System, Thermal Regulating
• Applicant: CINCINNATI SUB-ZERO 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-06-19
• Decision Date: 1981-07-16