MODEL 320 MR-COMPATIBLE PULSE OXIMETER
FDA 510(k) clearance K924282 · decided 1993-05-07
Clearance details
- K-number
- K924282
- Device name
- MODEL 320 MR-COMPATIBLE PULSE OXIMETER
- Applicant
- Magnetic Resonance Equipment Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-25
- Decision date
- 1993-05-07
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bay Shore, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.