The following data is part of a premarket notification filed by Noblitt & Rueland with the FDA for Bm3/bm3 Plus.
| Device ID | K132033 |
| 510k Number | K132033 |
| Device Name: | BM3/BM3 PLUS |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | NOBLITT & RUELAND 5405 ALTON PARKWAY SUITE A530 Irvine, CA 92604 -3718 |
| Contact | Marc Goodman |
| Correspondent | Marc Goodman NOBLITT & RUELAND 5405 ALTON PARKWAY SUITE A530 Irvine, CA 92604 -3718 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2013-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276940469 | K132033 | 000 |
| 18809276943641 | K132033 | 000 |