Models 246 and 210F Linear Array Ultrasound Scanner
FDA 510(k) K837304 · Aloka Co., Ltd.
510(k) numberK837304
Submission
- Device name
- Models 246 and 210F Linear Array Ultrasound Scanner
- Applicant
- Aloka Co., Ltd.
Tokyo, JP - Received
- March 18, 1983
- Decision date
- May 9, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K081843 | Ultrasound Data Analysis System, Model DAS-RS1LLZ · Traditional | 07/15/2008SE |
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| K072285 | Aloka Ssd-Alpha 7 Ultrasound SystemITX · Traditional | 08/30/2007SE |
| K060059 | Aloka SD-3500 Ultrasound SystemIYN · Traditional | 01/13/2006SE |
| K043196 | Aloka Ssd-Alpha 10 Ultrasound SystemIYN · Traditional | 11/30/2004SE |
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Questions and answers
When was Models 246 and 210F Linear Array Ultrasound Scanner cleared by the FDA?
Models 246 and 210F Linear Array Ultrasound Scanner (K837304) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 52 days after the submission was received.