The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Olympus-keymed Endoscopic Co2 Regulator, Model Ecr.
| Device ID | K881004 |
| 510k Number | K881004 |
| Device Name: | OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR |
| Classification | Insufflator, Automatic Carbon-dioxide For Endoscope |
| Applicant | KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Contact | Roger Gray |
| Correspondent | Roger Gray KEYMED, INC. KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA Essex Ss2 5qh England, GB |
| Product Code | FCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-09 |
| Decision Date | 1988-05-12 |