RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
FDA 510(k) clearance K012020 · decided 2001-08-21
Clearance details
- K-number
- K012020
- Device name
- RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC
- Applicant
- Non-Invasive Monitoring Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-06-28
- Decision date
- 2001-08-21
- Days to decision
- 54 days
- Clearance type
- Special
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.