FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
K Number: K041026
·
Decision Jun 28, 2004
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
328
Applicant Total
33
Review Days
68
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Basic Information
- Device Name
- AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
- K Number
- K041026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2360
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ambu, Inc.
- Date Received
- April 21, 2004
- Decision Date
- June 28, 2004
- Product Code
- DRX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | FDA class 2 | Cardiovascular |
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Other Clearances by Ambu, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051529 | AMBU NEUROLINE GROUND | Aug 4, 2005 | Substantially Equivalent |
| K042682 | AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR | Nov 15, 2004 | Substantially Equivalent |
| K042843 | AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS | Nov 12, 2004 | Substantially Equivalent |
| K041734 | AMBU DISPOSABLE ECG ELECTRODE | Sep 22, 2004 | Substantially Equivalent |
| K040991 | AMBU DISPOSABLE PRESSURE MANOMETER | Jul 22, 2004 | Substantially Equivalent |
| K032278 | AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE | Mar 5, 2004 | Substantially Equivalent |
| K032421 | AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE | Feb 27, 2004 | Substantially Equivalent |
| K010583 | AMBU GEL, HYDROGEL BURN DRESSING | May 25, 2001 | Substantially Equivalent |
| K993278 | AMBU NEONATE SILICONE RESUSCITATOR | May 17, 2000 | Substantially Equivalent |
| K992902 | AMBU HAND POWER SUCTION PUMP | Oct 25, 1999 | Substantially Equivalent |