PRESSUREGUARD IV
FDA 510(k) clearance K972486 · decided 1998-02-20
Clearance details
- K-number
- K972486
- Device name
- PRESSUREGUARD IV
- Applicant
- Span-America Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-02
- Decision date
- 1998-02-20
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- IKZ
- Device class
- 2
- Regulation number
- 890.5225
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Greenville, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.