4000+— 510(k) K950783
Substantially Equivalent for Some IndicationsU.S. Therapy Products, Inc.
FDA 510(k) clearance K950783 for 4000+, Substantially Equivalent for Some Indications on 1995-10-27. Applicant: U.S. Therapy Products, Inc.. Device class: 2.
Clearance details
- Applicant
- U.S. Therapy Products, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Edina, MN, US
Recent devices under product code IPF
view allData sourced from openFDA. This site is unofficial and independent of the FDA.