The following data is part of a premarket notification filed by Infantest Corp. with the FDA for Fagan Test Machine For Infant Intelligence.
| Device ID | K861304 |
| 510k Number | K861304 |
| Device Name: | FAGAN TEST MACHINE FOR INFANT INTELLIGENCE |
| Classification | Recorder, Attention Task Performance |
| Applicant | INFANTEST CORP. 2579 NORTH MORELAND, BLDG. D, SUITE 1 Shaker Heights, OH 44120 |
| Contact | Joseph Fagan |
| Correspondent | Joseph Fagan INFANTEST CORP. 2579 NORTH MORELAND, BLDG. D, SUITE 1 Shaker Heights, OH 44120 |
| Product Code | LQD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-09-23 |