FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARAMETERS MONITORES
K Number: K945099
·
Decision Jul 13, 1995
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
27
Review Days
268
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Basic Information
- Device Name
- PARAMETERS MONITORES
- K Number
- K945099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivy Biomedical Systems, Inc.
- Date Received
- October 18, 1994
- Decision Date
- July 13, 1995
- 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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