510(k) K881961
K881961 is an FDA 510(k) premarket notification submitted by Med Service, Inc. for the device "MSI STANDARD BED MODELS: L1097-64 AND L1085-64". The FDA issued a decision of Substantially Equivalent on November 1, 1988. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Med Service, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1988
- Date Received
- May 10, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bed, Manual
- Device Class
- Class I
- Regulation Number
- 880.5120
- Review Panel
- HO
- Submission Type