The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Deltatalker With Infrared.
| Device ID | K961306 |
| 510k Number | K961306 |
| Device Name: | DELTATALKER WITH INFRARED |
| Classification | System, Environmental Control, Powered |
| Applicant | PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
| Contact | Dave Hershberger |
| Correspondent | Dave Hershberger PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
| Product Code | IQA |
| CFR Regulation Number | 890.3725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-04 |
| Decision Date | 1996-06-27 |