FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Q-PLEX 1
K Number: K881235
·
Decision Mar 31, 1989
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
89
Applicant Total
164
Review Days
374
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Q-PLEX 1
- K Number
- K881235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1880
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Quinton, Inc.
- Date Received
- March 22, 1988
- Decision Date
- March 31, 1989
- Product Code
- BZC
- 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZC), ordered by most recent decision date.
STS
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus/SentrySuite Product Line
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus BODY
FDA 510(k)
FDA Class 2
·Anesthesiology
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
FDA 510(k)
FDA Class 2
·Anesthesiology
COSMED K5 Wearable Metabolic Technology
FDA 510(k)
FDA Class 2
·Anesthesiology
MiniBox +
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Quinton, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |