FDA 510(k)
Substantially Equivalent
🇺🇸 United States
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
K Number: K961014
·
Decision Jul 31, 1996
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
164
Review Days
140
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Basic Information
- Device Name
- QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
- K Number
- K961014
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quinton, Inc.
- Date Received
- March 13, 1996
- Decision Date
- July 31, 1996
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LOS), ordered by most recent decision date.
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|---|---|---|---|
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| 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 |
| 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 |