FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C/PES 9201, ECG STRESS TESTING SYS
K Number: K850114
·
Decision Feb 22, 1985
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
334
Applicant Total
31
Review Days
39
Basic Information
- Device Name
- C/PES 9201, ECG STRESS TESTING SYS
- K Number
- K850114
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- GOULD, INC.
- Date Received
- January 14, 1985
- Decision Date
- February 22, 1985
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by GOULD, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | Jul 22, 1991 | Substantially Equivalent |
| K861092 | MODEL SP1465 CARDIAC OUTPUT COMPUTER | Aug 18, 1986 | Substantially Equivalent |
| K860805 | PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 | May 8, 1986 | Substantially Equivalent |
| K855145 | MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR | Feb 26, 1986 | Substantially Equivalent |
| K854403 | MODEL 2120 SPIROSCREEN | Jan 14, 1986 | Substantially Equivalent |
| K851486 | GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX | Oct 17, 1985 | Substantially Equivalent |
| K850113 | C/PES 9103, ECG STRESS TESTING SYSTEM | Feb 8, 1985 | Substantially Equivalent |
| K843555 | CARDIAC COMPUTER SP1445 | Feb 1, 1985 | Substantially Equivalent |
| K843969 | MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER | Jan 23, 1985 | Substantially Equivalent |
| K843970 | MODEL IM1074 END-TIDAL CO2 MODULE | Oct 24, 1984 | Substantially Equivalent |