Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Prentke Romich Co. with 9 510(k) clearances. The most recent is a 510(k) clearance dated Jun 27, 1996: DELTATALKER WITH INFRARED.
| Jun 27, 1996 | DELTATALKER WITH INFRAREDK961306 · IQA | 510(k) clearances |
| Feb 21, 1995 | SCANNING DIRECTORK944585 · IQA | 510(k) clearances |
| Mar 28, 1994 | ALPHA TALKERK935317 · ITI | 510(k) clearances |
| Mar 28, 1994 | WALKERTALKERK933207 · ITI | 510(k) clearances |
| Mar 29, 1993 | LIBERATORK925387 · ILQ | 510(k) clearances |
| Mar 22, 1993 | LIGHT TALKERK925527 · ILQ | 510(k) clearances |
| Feb 27, 1992 | TOUCH TALKERK914259 · ILQ | 510(k) clearances |
| Jul 25, 1990 | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1K902664 · IQA | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
