510(k) K884908
K884908 is an FDA 510(k) premarket notification submitted by Medical Flotation Systems, Inc. for the device "ULTRAFLOTATION MEDICAL WHEELCHAIR". The FDA issued a decision of Substantially Equivalent on December 27, 1988. The device falls under product code INF (Scale, Platform, Wheelchair), a Class I device regulated under 21 CFR 890.3940. Medical Flotation Systems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 1988
- Date Received
- November 23, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scale, Platform, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3940
- Review Panel
- PM
- Submission Type