510(k) K896510

TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. by Technical Medical Products, Inc. — Product Code CBN

K896510 is an FDA 510(k) premarket notification submitted by Technical Medical Products, Inc. for the device "TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR.". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Technical Medical Products, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
November 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type