510(k) K993414
K993414 is an FDA 510(k) premarket notification submitted by Prucka Engineering, Inc. for the device "PRUCKA ENGINEERING INC. CARDIOLAB EP SYSTEM,VERSION 4.2". The FDA issued a decision of Substantially Equivalent on April 7, 2000. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Prucka Engineering, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 7, 2000
- Date Received
- October 12, 1999
- 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