510(k) K820963
K820963 is an FDA 510(k) premarket notification submitted by Pryor Products for the device "PATIENT PAL I.V. WALKER". The FDA issued a decision of Substantially Equivalent on April 21, 1982. The device falls under product code FOX (Stand, Infusion), a Class I device regulated under 21 CFR 880.6990. Pryor Products has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1982
- Date Received
- April 6, 1982
- 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