DRS SYSTEM
FDA 510(k) clearance K981822 · decided 1998-06-24
Clearance details
- K-number
- K981822
- Device name
- DRS SYSTEM
- Applicant
- Professional Distribution Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-22
- Decision date
- 1998-06-24
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- ITH
- Device class
- 2
- Regulation number
- 890.5900
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Boca Raton, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.