FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 320 MR-COMPATIBLE PULSE OXIMETER
K Number: K924282
·
Decision May 7, 1993
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
5
Review Days
255
Basic Information
- Device Name
- MODEL 320 MR-COMPATIBLE PULSE OXIMETER
- K Number
- K924282
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MAGNETIC RESONANCE EQUIPMENT CORP.
- Date Received
- August 25, 1992
- Decision Date
- May 7, 1993
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by MAGNETIC RESONANCE EQUIPMENT CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K003982 | TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR | Jan 26, 2001 | Substantially Equivalent |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR | Dec 12, 1999 | Substantially Equivalent |
| K954120 | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR | Apr 2, 1997 | Substantially Equivalent |
| K924285 | MODEL 3500 MR-COMPATIBLE PULSE OXIMETER | May 11, 1993 | Substantially Equivalent |