High Frequency Linear Array (Hfla) Scanhead
FDA 510(k) K872068 · Advanced Technology Laboratories, Inc.
510(k) numberK872068
Submission
- Device name
- High Frequency Linear Array (Hfla) Scanhead
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- May 29, 1987
- Decision date
- September 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was High Frequency Linear Array (Hfla) Scanhead cleared by the FDA?
High Frequency Linear Array (Hfla) Scanhead (K872068) received a 510(k) decision of Substantially Equivalent on September 30, 1987, 124 days after the submission was received.
What is the product code of K872068?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.