510(k) K033513
- Device
- EASI ECG ALGORITHM
- Applicant
- PHILIPS MEDICAL SYSTEMS
- 510(k) number
- K033513
- Product code
- DRW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-01-15
- Date received
- 2003-11-06
- Regulation
- 870.2350
- Classification name
- Adaptor, Lead Switching, Electrocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID OSBORN
- Address
- 3000 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3010703925
- 3013500228
- 1218950
- 3012528160
- 3013596024
- 3000126629
- 3016618143
- 9610816
- 3009077524
- 3003263092
- 3016701404
Source Documents#
Other 510(k) Records For Product Code DRW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020456 | EASI 12 LEAD ALGORITHM | Philips Medical Systems | 2002-07-09 |
| K930786 | EPCOR | Siemens Medical Solutions USA, Inc. | 1994-09-26 |
| K872781 | EASI LEAD SYSTEM CABLE ASSEMBLY | Totemite Medical Electronics | 1987-12-29 |
| K861981 | ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR | Vital Signs, Inc. | 1986-08-25 |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | Eaton Medical Group | 1985-11-08 |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Eaton Medical Group | 1985-11-08 |
| K761210 | LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) | Physio-Control Corp. | 1976-12-21 |
Legacy Summary#
summary
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