510(k) K954387

T CLASS HYPERBARIC FACILITIES by Reimers Systems, Inc. — Product Code CBF

K954387 is an FDA 510(k) premarket notification submitted by Reimers Systems, Inc. for the device "T CLASS HYPERBARIC FACILITIES". The FDA issued a decision of Substantially Equivalent on December 15, 1995. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Reimers Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1995
Date Received
August 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type