510(k) K881043

FOLDING HOSPITAL COT NSN 6530-00-299-8517 by Junkin Safety Appliance Co., Inc. — Product Code FNJ

K881043 is an FDA 510(k) premarket notification submitted by Junkin Safety Appliance Co., Inc. for the device "FOLDING HOSPITAL COT NSN 6530-00-299-8517". The FDA issued a decision of Substantially Equivalent on April 12, 1988. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Junkin Safety Appliance Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1988
Date Received
March 11, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Manual
Device Class
Class I
Regulation Number
880.5120
Review Panel
HO
Submission Type