510(k) K061428
K061428 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "PMP4 APPLICATION". The FDA issued a decision of Substantially Equivalent on October 16, 2006. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2006
- Date Received
- May 23, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type