FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAVROLAB
K Number: K882585
·
Decision Mar 2, 1989
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
68
Review Days
253
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
- CAVROLAB
- K Number
- K882585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Intl., Inc.
- Date Received
- June 22, 1988
- Decision Date
- March 2, 1989
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYN), ordered by most recent decision date.
ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
ES-Series
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
FDA 510(k)
FDA Class 2
·Radiology
LOGIQ e
FDA 510(k)
FDA Class 2
·Radiology
SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Life-Tech Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001129 | PROLONG, MODELS PL50, PL100, PL150 | Jul 6, 2000 | Substantially Equivalent |
| K955031 | MAXISTIM | Dec 10, 1996 | Substantially Equivalent |
| K954505 | EZ STIM | Dec 10, 1996 | Substantially Equivalent |
| K954315 | PVC ABDOMINAL/RECTAL PRESSURE CATHETER | Nov 30, 1995 | Substantially Equivalent |
| K954341 | URODYNAMICS TUBING AND INFUSION SETS | Oct 17, 1995 | Substantially Equivalent |
| K953451 | UROPUMP TUBE & DAMPING CHAMGER | Oct 5, 1995 | Substantially Equivalent |
| K953353 | UROVISION JANUS | Sep 8, 1995 | Substantially Equivalent |
| K946108 | EAR-A-GATOR | Jun 13, 1995 | Substantially Equivalent |
| K913601 | MICROPHOR | Jul 15, 1994 | Substantially Equivalent |
| K940203 | TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS | Mar 30, 1994 | Substantially Equivalent |