510(k) K932240

MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS by Bailey Mfg. Co. — Product Code IRR

K932240 is an FDA 510(k) premarket notification submitted by Bailey Mfg. Co. for the device "MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS". The FDA issued a decision of Substantially Equivalent on April 1, 1994. The device falls under product code IRR (Bars, Parallel, Powered), a Class I device regulated under 21 CFR 890.5380. Bailey Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1994
Date Received
May 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bars, Parallel, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type