510(k) K881843
K881843 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "PEDIATRIC HOSPITAL BED". The FDA issued a decision of Substantially Equivalent on October 26, 1988. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 1988
- Date Received
- May 2, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Flotation Therapy, Powered
- Device Class
- Class II
- Regulation Number
- 890.5170
- Review Panel
- PM
- Submission Type