FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
K Number: K990400
·
Decision Feb 24, 1999
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
230
Review Days
15
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
- K Number
- K990400
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hewlett-Packard Co.
- Date Received
- February 9, 1999
- Decision Date
- February 24, 1999
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
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 |
| K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | Feb 18, 1999 | Substantially Equivalent |