The following data is part of a premarket notification filed by Biomedical Systems Corp. with the FDA for Century Series Holter Scanner System, Models C3000, C2000 And C1000.
| Device ID | K024323 |
| 510k Number | K024323 |
| Device Name: | CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 |
| Classification | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Applicant | BIOMEDICAL SYSTEMS CORP. 2464 WEST PORT PLAZA DR. St. Louis, MO 63146 |
| Contact | K. Michael Kroehnke |
| Correspondent | K. Michael Kroehnke BIOMEDICAL SYSTEMS CORP. 2464 WEST PORT PLAZA DR. St. Louis, MO 63146 |
| Product Code | MLO |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-26 |
| Decision Date | 2003-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146C1MA051010 | K024323 | 000 |
| B146C1MA080 | K024323 | 000 |
| B146C2MA000 | K024323 | 000 |
| B146C2MA080 | K024323 | 000 |
| B146C3MA00 | K024323 | 000 |
| B146C3MA020 | K024323 | 000 |
| B146C3MA050 | K024323 | 000 |
| B146C3MA070 | K024323 | 000 |
| B146C3MA080 | K024323 | 000 |
| B146C4MA000 | K024323 | 000 |
| B146C4MA020 | K024323 | 000 |
| B146C4MA080 | K024323 | 000 |
| B146C1MA001010 | K024323 | 000 |
| B146C1MA011010 | K024323 | 000 |
| B146C1MA021010 | K024323 | 000 |
| B146C1MA031010 | K024323 | 000 |
| B146C1MA041010 | K024323 | 000 |
| B146C1MA070 | K024323 | 000 |