FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CRASH CART
K Number: K832355
·
Decision Oct 28, 1983
Classifications
1
FEI Numbers
135
Registration Numbers
135
Same Product Code
7
Applicant Total
164
Review Days
102
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Basic Information
- Device Name
- CRASH CART
- K Number
- K832355
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6175
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- July 18, 1983
- Decision Date
- October 28, 1983
- Product Code
- BZN
- 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 |
|---|---|---|---|
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) | FDA class 1 | Anesthesiology |
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|---|---|---|---|
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| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | Jan 25, 2001 | Substantially Equivalent |
| K001492 | QUINTON Q-STRESS, MODEL 000483 | Aug 9, 2000 | Substantially Equivalent |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | Mar 6, 2000 | Substantially Equivalent |
| K990866 | QUINTON MEDTRACK CR PLUS TREADMILL | Apr 29, 1999 | Substantially Equivalent |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Aug 25, 1997 | Substantially Equivalent |
| K964784 | SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) | Aug 13, 1997 | Substantially Equivalent |
| K964978 | VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) | May 21, 1997 | Substantially Equivalent |
| K955002 | MAHURKAR 8 FR DUAL LEMEN CATHETER | Sep 13, 1996 | Substantially Equivalent |