Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- FYHSplint, Extremity, Noninflatable, External, Sterile1Product Code
- K925145TRACE MODEL #'S 840, 841, 842, 8451Cleared 510(K)
- K924984SPECIALIST(R) WALKER1Cleared 510(K)
- K895092KUT-SHIELD1Cleared 510(K)
- K852558SPLINTS(ALL TYPE)1Cleared 510(K)
- K843400HYDRO-SPLINT A SPONGE-COMPRESS DRESS1Cleared 510(K)
- K821693J & J DIP WATER ADDITIVE1Cleared 510(K)
- K802522DELTA-LITE CASTING TAPE & SPLINTS1Cleared 510(K)
- K801436ORTHOPEDIC LOWER EXTREMITY SUSPENSION1Cleared 510(K)
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
TRACE MODEL #'S 840, 841, 842, 845
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K925145
- 510(k) Type
- Traditional
- Applicant
- TRACE MEDICAL EQUIPMENT, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/1993
- Days to Decision
- 218 days
- Submission Type
- Statement