510(k) K071885
- Device
- ANTIMICROBIAL AND SINGLE-PATIENT CUFFS
- Applicant
- PHILIPS MEDICAL SYSTEMS
- 510(k) number
- K071885
- Product code
- OED
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-20
- Date received
- 2007-07-09
- Regulation
- 870.1120
- Classification name
- Antimicrobial Blood Pressure Cuff
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER SCHIPELLITI
- Address
- 3000 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3004727093
- 3014541700
- 1222630
- 9610816
- 3000126629
- 1218950
- 3010157426
- 3016618143
Source Documents#
Other 510(k) Records For Product Code OED #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122365 | ULTRACHECK CURVE BLOOD PRESSURE CUFFS | Statcorp Medical | 2013-06-04 |
Legacy Summary#
summary
FDA Review#
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