510(k) K032403
- Device
- SMARTMONITOR 2 PROFESSIONAL SERIES (PS)
- Applicant
- RESPIRONICS, INC.
- 510(k) number
- K032403
- Product code
- NPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-10-27
- Date received
- 2003-08-04
- Regulation
- 868.2377
- Classification name
- Monitor, Apnea, Home Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- 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#
Other 510(k) Records For Product Code NPF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061256 | SMARTMONITOR 2PS | Respironics, Inc. | 2006-08-02 |
Legacy Summary#
summary
FDA Review#
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