The following data is part of a premarket notification filed by Beecher Medical Diagnostic Instrumentation with the FDA for Napsac(tm).
| Device ID | K871830 |
| 510k Number | K871830 |
| Device Name: | NAPSAC(TM) |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION 9007 WOODLAND DR. Silver Spring, MD 20910 |
| Contact | Stephen Leighton,dsc |
| Correspondent | Stephen Leighton,dsc BEECHER MEDICAL DIAGNOSTIC INSTRUMENTATION 9007 WOODLAND DR. Silver Spring, MD 20910 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-11 |
| Decision Date | 1987-09-09 |