510(k) K874326
K874326 is an FDA 510(k) premarket notification submitted by Air-Shields, Inc. for the device "SYSTEM VI MONITOR". The FDA issued a decision of Substantially Equivalent on Dec 5, 1988. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Air-Shields, Inc. has 32 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 5, 1988
- Date Received
- Oct 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type
- 510(k)