The following data is part of a premarket notification filed by Dni Nevada, Inc. with the FDA for Sigma Pace External Pacemaker Analyzer Model #1000.
| Device ID | K011729 |
| 510k Number | K011729 |
| Device Name: | SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 |
| Classification | Analyzer, Pacemaker Generator Function |
| Applicant | DNI NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Contact | Kristine Boggs |
| Correspondent | Kristine Boggs DNI NEVADA, INC. 2000 ARROWHEAD DR. Carson City, NV 89706 -0403 |
| Product Code | DTC |
| CFR Regulation Number | 870.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850540007157 | K011729 | 000 |