The following data is part of a premarket notification filed by Prentke Romich Co. with the FDA for Hospital/home Environmental Control Syst/hecs-1.
| Device ID | K902664 |
| 510k Number | K902664 |
| Device Name: | HOSPITAL/HOME ENVIRONMENTAL CONTROL SYST/HECS-1 |
| Classification | System, Environmental Control, Powered |
| Applicant | PRENTKE ROMICH CO. 1022 HEYL RD. Wooster, OH 44691 |
| Contact | Steven Crisafulli |
| Correspondent | Steven Crisafulli 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 | 1990-06-18 |
| Decision Date | 1990-07-25 |