510(k) K932240
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