Submission Details
| 510(k) Number | K990400 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 09, 1999 |
| Decision Date | February 24, 1999 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
Feb 1999
Decision
15d
Days
Class 2
Risk
About This 510(k) Submission
K990400 is an FDA 510(k) clearance for the LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM, a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on February 24, 1999, 15 days after receiving the submission on February 9, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.
Device Classification
| Product Code | ITX — Transducer, Ultrasonic, Diagnostic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1570 |
Manufacturer
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