510(k) K952196
K952196 is an FDA 510(k) premarket notification submitted by Valentine Intl. , Ltd. for the device "IV POLE/STAND". The FDA issued a decision of Substantially Equivalent on July 31, 1995. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Valentine Intl. , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1995
- Date Received
- May 9, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stand, Infusion
- Device Class
- Class I
- Regulation Number
- 880.6990
- Review Panel
- HO
- Submission Type