DIGITEC TWO STAGE COMPRESSION KIT
FDA 510(k) clearance K993681 · decided 1999-12-21
Clearance details
- K-number
- K993681
- Device name
- DIGITEC TWO STAGE COMPRESSION KIT
- Applicant
- Digitec Medical Service Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-01
- Decision date
- 1999-12-21
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- IZH
- Device class
- 2
- Regulation number
- 892.1710
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lawrenceville, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.