FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARO-GRAF 24
K Number: K881297
·
Decision Sep 16, 1988
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
147
Applicant Total
32
Review Days
172
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
- BARO-GRAF 24
- K Number
- K881297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2850
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Instromedix, Inc.
- Date Received
- March 28, 1988
- Decision Date
- September 16, 1988
- Product Code
- DRS
- 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 |
|---|---|---|---|
| DRS | Transducer, Blood-Pressure, Extravascular | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRS), ordered by most recent decision date.
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
FDA 510(k)
FDA Class 2
·Cardiovascular
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
FDA 510(k)
FDA Class 2
·Cardiovascular
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
Compass Cast and MAP
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Pressure Transducer
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Instromedix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964408 | POSEIDON CARDIAC MONITORING SYSTEM (PCMS) | Jul 23, 1997 | Substantially Equivalent |
| K964036 | CARDIOMAGIC 2000 SOFTWARE | Jul 18, 1997 | Substantially Equivalent |
| K955060 | ACCELERATED TRANSMISSION PROTOCOL | Apr 8, 1996 | Substantially Equivalent |
| K951096 | LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER | Jan 16, 1996 | Substantially Equivalent |
| K945476 | HEARTHWATCH III(TM) | Nov 9, 1995 | Substantially Equivalent |
| K950003 | CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS | Oct 31, 1995 | Substantially Equivalent |
| K944362 | HEARTCARD CARDIAC EVENT MONITOR | Sep 7, 1995 | Substantially Equivalent |
| K943931 | CARRYALL ENHANCEMENTS | Apr 4, 1995 | Substantially Equivalent |
| K935586 | PRINCE | Nov 8, 1994 | Substantially Equivalent |
| K925639 | CARDIOMAGIC SOFTWARE | Jun 22, 1993 | Substantially Equivalent |