The following data is part of a premarket notification filed by Acumed Technologies, Inc. with the FDA for Acumed 9000 Etco(2) Monitor.
| Device ID | K882661 |
| 510k Number | K882661 |
| Device Name: | ACUMED 9000 ETCO(2) MONITOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | ACUMED TECHNOLOGIES, INC. P.O. BOX 0925 Waukesha, WI 53187 |
| Contact | Daniel F Carsten |
| Correspondent | Daniel F Carsten ACUMED TECHNOLOGIES, INC. P.O. BOX 0925 Waukesha, WI 53187 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-28 |
| Decision Date | 1988-08-24 |