The following data is part of a premarket notification filed by Hd Medical Services (india) Pvt.ltd with the FDA for Viscope, Model 100p,100s.
| Device ID | K100531 |
| 510k Number | K100531 |
| Device Name: | VISCOPE, MODEL 100P,100S |
| Classification | Stethoscope, Electronic |
| Applicant | HD MEDICAL SERVICES (INDIA) PVT.LTD 11143 TWINLEAF WAY San Diego, CA 92131 |
| Contact | Bill Murphy |
| Correspondent | Bill Murphy HD MEDICAL SERVICES (INDIA) PVT.LTD 11143 TWINLEAF WAY San Diego, CA 92131 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-24 |
| Decision Date | 2010-07-21 |
| Summary: | summary |