The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Ultrasonic Scanner Calibration & Test Phantoms.
| Device ID | K844247 |
| 510k Number | K844247 |
| Device Name: | ULTRASONIC SCANNER CALIBRATION & TEST PHANTOMS |
| Classification | Block, Test, Ultrasonic Scanner Calibration |
| Applicant | TECHNICARE CORP. 90 INVERNESS CIRCLE EAST Englewood, CO 80112 |
| Contact | David A Ensor |
| Correspondent | David A Ensor TECHNICARE CORP. 90 INVERNESS CIRCLE EAST Englewood, CO 80112 |
| Product Code | GXX |
| CFR Regulation Number | 882.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-01 |
| Decision Date | 1985-01-23 |