FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORTABLE PATIENT MONITOR
K Number: K922974
·
Decision Dec 7, 1992
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
411
Applicant Total
230
Review Days
168
Basic Information
- Device Name
- PORTABLE PATIENT MONITOR
- K Number
- K922974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- HEWLETT-PACKARD CO.
- Date Received
- June 22, 1992
- Decision Date
- December 7, 1992
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MHX), ordered by most recent decision date.
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P
FDA 510(k)
FDA Class 2
·Cardiovascular
Radius VSM and Accessories
FDA 510(k)
FDA Class 2
·Cardiovascular
Telemetry Monitor 5500 Release 4.0 (867232)
FDA 510(k)
FDA Class 2
·Cardiovascular
Infinity CentralStation Wide
FDA 510(k)
FDA Class 2
·Cardiovascular
Patient Monitor (RespArray)
FDA 510(k)
FDA Class 2
·Cardiovascular
Corvair
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by HEWLETT-PACKARD CO.
| K Number | Device Name | ||
|---|---|---|---|
| K992543 | HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE | May 18, 2000 | Substantially Equivalent |
| K993587 | HP M2376A DEVICE LINK SYSTEM | Jan 20, 2000 | Substantially Equivalent |
| K993169 | MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A | Dec 20, 1999 | Substantially Equivalent |
| K992977 | HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A | Dec 1, 1999 | Substantially Equivalent |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | Nov 8, 1999 | Substantially Equivalent |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | Oct 21, 1999 | Substantially Equivalent |
| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | Aug 31, 1999 | Substantially Equivalent |
| K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A | Aug 5, 1999 | Substantially Equivalent |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Apr 30, 1999 | Substantially Equivalent |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | Feb 24, 1999 | Substantially Equivalent |