3MHZ Annular Array
510(k) K864980
3MHZ Annular Array is a Class II device made by Philips Ultrasound, Inc., cleared under FDA 510(k) K864980 on 11 May 1987, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864980 | Date11 May 1987 | StatusActive |
Official records
- FDA 510(k) database K864980
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOP
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2880
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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- GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER by Biosound, Inc.
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