ACTIHEART
Conditioner, Signal, Physiological
RESPIRONICS, INC.
The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Actiheart.
Pre-market Notification Details
| Device ID | K052489 |
| 510k Number | K052489 |
| Device Name: | ACTIHEART |
| Classification | Conditioner, Signal, Physiological |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Zita A Yurko |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | GWK |
| CFR Regulation Number | 882.1845 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-09-12 |
| Decision Date | 2005-09-27 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B329AH420 | K052489 | 000 |
| B329AHBT56 | K052489 | 000 |
| B329AH556 | K052489 | 000 |
Trademark Results [ACTIHEART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTIHEART 76472072 3016645 Live/Registered |
CAMNTECH LIMITED 2002-11-29 |
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