Submission Details
| 510(k) Number | K002397 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 07, 2000 |
| Decision Date | August 17, 2000 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER
Aug 2000
Decision
10d
Days
Class 2
Risk
About This 510(k) Submission
K002397 is an FDA 510(k) clearance for the M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on August 17, 2000, 10 days after receiving the submission on August 7, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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