510(k) K911246
K911246 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2". The FDA issued a decision of Substantially Equivalent on Jun 6, 1991. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. The Medical Group, Inc. has 15 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 6, 1991
- Date Received
- Mar 21, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Air Fluidized
- Device Class
- Class II
- Regulation Number
- 890.5160
- Review Panel
- PM
- Submission Type
- 510(k) Exempt