510(k) K872876
K872876 is an FDA 510(k) premarket notification submitted by Intl. Management Services, Inc. for the device "IMSI/EASY FLOAT MATTRESS". The FDA issued a decision of Substantially Equivalent on October 13, 1987. The device falls under product code FOH (Mattress, Water, Temperature Regulated), a Class I device regulated under 21 CFR 880.5560. Intl. Management Services, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1987
- Date Received
- July 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mattress, Water, Temperature Regulated
- Device Class
- Class I
- Regulation Number
- 880.5560
- Review Panel
- HO
- Submission Type