INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
FDA 510(k) clearance K983250 · decided 1999-12-12
Clearance details
- K-number
- K983250
- Device name
- INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
- Applicant
- Magnetic Resonance Equipment Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-09-16
- Decision date
- 1999-12-12
- Days to decision
- 452 days
- Clearance type
- Traditional
- Product code
- DSK
- Device class
- 2
- Regulation number
- 870.1110
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bay Shore, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Magnetic Resonance Equipment Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasiv recall (Z-0258-2007) | Medrad Inc | 2006-12-15 |