510(k) K873612
K873612 is an FDA 510(k) premarket notification submitted by Intl. Management Services, Inc. for the device "IMSI, VITAL CALL". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code IQA (System, Environmental Control, Powered), a Class II device regulated under 21 CFR 890.3725. Intl. Management Services, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1987
- Date Received
- September 8, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Environmental Control, Powered
- Device Class
- Class II
- Regulation Number
- 890.3725
- Review Panel
- PM
- Submission Type