FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUINTON Q-STRESS, MODEL 000483
K Number: K001492
·
Decision Aug 9, 2000
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
574
Applicant Total
164
Review Days
89
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Basic Information
- Device Name
- QUINTON Q-STRESS, MODEL 000483
- K Number
- K001492
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quinton, Inc.
- Date Received
- May 12, 2000
- Decision Date
- August 9, 2000
- Product Code
- DPS
- 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 |
|---|---|---|---|
| DPS | Electrocardiograph | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K032038 | PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 | Sep 5, 2003 | Substantially Equivalent |
| K021906 | QUINTON Q-CATH, MODEL 000460 | Sep 4, 2002 | Substantially Equivalent |
| K003576 | Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 | Jan 25, 2001 | 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 |
| K961014 | QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH | Jul 31, 1996 | Substantially Equivalent |