510(k) K945385
K945385 is an FDA 510(k) premarket notification submitted by Pace Tech, Inc. for the device "VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300". The FDA issued a decision of Substantially Equivalent on January 31, 1995. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Pace Tech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1995
- Date Received
- November 3, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type