FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K Number: K844149
·
Decision Nov 15, 1984
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
33
Review Days
22
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Basic Information
- Device Name
- AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
- K Number
- K844149
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ambu, Inc.
- Date Received
- October 24, 1984
- Decision Date
- November 15, 1984
- Product Code
- CAI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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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 |
| K041026 | AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S | Jun 28, 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 |