FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITALMAX 4000
K Number: K933624
·
Decision Jul 19, 1994
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
18
Review Days
365
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Basic Information
- Device Name
- VITALMAX 4000
- K Number
- K933624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pace Tech, Inc.
- Date Received
- July 19, 1993
- Decision Date
- July 19, 1994
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Pace Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K951226 | VITALMAX 4000/MINIPACK 3100/3000 | Nov 21, 1996 | Substantially Equivalent |
| K953795 | VITALMAX 4100 | Jul 1, 1996 | Substantially Equivalent |
| K944541 | HANDYPACK 911SC | Feb 22, 1995 | Substantially Equivalent |
| K945385 | VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 | Jan 31, 1995 | Substantially Equivalent |
| K925701 | MINIPACK 911-STC | Aug 11, 1994 | Substantially Equivalent |
| K934385 | MINIPACK 3100/3000 MODIFICATION | Aug 10, 1994 | Substantially Equivalent |
| K930559 | VITALMAX 800-C | Sep 3, 1993 | Substantially Equivalent |
| K912835 | MINI-PACK 911 SERIES | Feb 3, 1992 | Substantially Equivalent |
| K912880 | VITALMAX 510/520 | Nov 14, 1991 | Substantially Equivalent |
| K913263 | VITALMAX 830 SERIES | Oct 10, 1991 | Substantially Equivalent |