510(k) K061256
- Device
- SMARTMONITOR 2PS
- Applicant
- RESPIRONICS, INC.
- 510(k) number
- K061256
- Product code
- NPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-02
- Date received
- 2006-05-04
- Regulation
- 868.2377
- Classification name
- Monitor, Apnea, Home Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ZITA A YURKO
- Address
- 1001 Murry Ridge Ln. Murrysville PA US 15668 15668
FDA Registration Numbers#
- 9680215
- 3006182632
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032403 | SMARTMONITOR 2 PROFESSIONAL SERIES (PS) | Respironics, Inc. | 2003-10-27 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases