BPCALIBRATOR MC3000/MC3100
System, Measurement, Blood-pressure, Non-invasive
HEALTHSTATS INTERNATIONAL PTE. LTD.
The following data is part of a premarket notification filed by Healthstats International Pte. Ltd. with the FDA for Bpcalibrator Mc3000/mc3100.
Pre-market Notification Details
| Device ID | K051546 |
| 510k Number | K051546 |
| Device Name: | BPCALIBRATOR MC3000/MC3100 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HEALTHSTATS INTERNATIONAL PTE. LTD. 565 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-06-24 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|
| 08885014410029 |
K051546 |
000 |
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