The following data is part of a premarket notification filed by Respironics Georgia, Inc. with the FDA for Smartmonitor 2, Model 4000.
| Device ID | K011597 |
| 510k Number | K011597 |
| Device Name: | SMARTMONITOR 2, MODEL 4000 |
| Classification | Monitor, Apnea, Facility Use |
| Applicant | RESPIRONICS GEORGIA, INC. 175 CHASTAIN MEADOWS COURT Kennesaw, GA 30144 |
| Contact | Betsy Cortelloni |
| Correspondent | Betsy Cortelloni RESPIRONICS GEORGIA, INC. 175 CHASTAIN MEADOWS COURT Kennesaw, GA 30144 |
| Product Code | FLS |
| CFR Regulation Number | 868.2377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-24 |
| Decision Date | 2002-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0364003 | K011597 | 000 |
| B0364002 | K011597 | 000 |