The following data is part of a premarket notification filed by Neotronics Medical Ltd. with the FDA for Era 2000 Emergency Resuscitator.
| Device ID | K884089 |
| 510k Number | K884089 |
| Device Name: | ERA 2000 EMERGENCY RESUSCITATOR |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | NEOTRONICS MEDICAL LTD. PARSONAGE ROAD Bishop's Stortford, GB |
| Contact | Stan Cherry |
| Correspondent | Stan Cherry NEOTRONICS MEDICAL LTD. PARSONAGE ROAD Bishop's Stortford, GB |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-28 |
| Decision Date | 1988-12-20 |