The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Ethox Neonatal Blood Pressure Cuff-sterile/dispos..
| Device ID | K844988 |
| 510k Number | K844988 |
| Device Name: | ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS. |
| Classification | Blood Pressure Cuff |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | Frank P Wilton |
| Correspondent | Frank P Wilton ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-04-04 |