510(k) K903652
K903652 is an FDA 510(k) premarket notification submitted by Med Labs, Inc. for the device "SCAN COM AND SCAN COM P (TENTATIVE)". The FDA issued a decision of Substantially Equivalent on August 24, 1990. The device falls under product code ILQ (System, Communication, Powered), a Class II device regulated under 21 CFR 890.3710. Med Labs, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1990
- Date Received
- August 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Communication, Powered
- Device Class
- Class II
- Regulation Number
- 890.3710
- Review Panel
- PM
- Submission Type