PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
FDA 510(k) clearance K980087 · decided 1998-07-01
Clearance details
- K-number
- K980087
- Device name
- PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
- Applicant
- Pressure Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-09
- Decision date
- 1998-07-01
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rancho Palos Verdes, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.