FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
YSI MODEL 23L LACTATE ANALYZER
K Number: K822812
·
Decision Dec 13, 1982
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
23
Review Days
84
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Basic Information
- Device Name
- YSI MODEL 23L LACTATE ANALYZER
- K Number
- K822812
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Yellow Springs Instrument Co., Inc.
- Date Received
- September 20, 1982
- Decision Date
- December 13, 1982
- Product Code
- HHP
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| HHP | Table, Obstetrical, Manual (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHP), ordered by most recent decision date.
View allOther 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 |