510(k) K893597
K893597 is an FDA 510(k) premarket notification submitted by Arthro-Medic, Inc. for the device "HYDRAULIC IV POLE". The FDA issued a decision of Substantially Equivalent on October 10, 1989. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Arthro-Medic, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1989
- Date Received
- May 9, 1989
- 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