FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
K Number: K823232
·
Decision Dec 7, 1982
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
23
Review Days
39
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Basic Information
- Device Name
- YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
- K Number
- K823232
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Yellow Springs Instrument Co., Inc.
- Date Received
- October 29, 1982
- Decision Date
- December 7, 1982
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Yellow Springs Instrument Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE | Jul 19, 1996 | Substantially Equivalent |
| K922821 | YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES | Nov 23, 1992 | Substantially Equivalent |
| K922007 | YSI MODEL 441A AIRWAY TEMPERATURE PROBE | Nov 4, 1992 | Substantially Equivalent |
| K910633 | YSI MODEL 1500 BLOOD GLUCOSE ANALYZER | Apr 12, 1991 | Substantially Equivalent |
| K910718 | YSI PRECISION 4000 THERMOMETER | Apr 9, 1991 | Substantially Equivalent |
| K901131 | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | Aug 27, 1990 | Substantially Equivalent for Some Indications |
| K893409 | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP | Jul 20, 1989 | Substantially Equivalent |
| K891480 | YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER | May 22, 1989 | Substantially Equivalent |
| K883793 | DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) | Nov 21, 1988 | Substantially Equivalent |
| K865012 | YSI MODEL 801 | Mar 4, 1987 | Substantially Equivalent |