Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- KZMDevice, Muscle Monitoring2Product Code
- K161716TEETHAN 2.02Cleared 510(K)
- K130158M-SCAN2Cleared 510(K)
- K113677GRINDCARE MEASURE2Cleared 510(K)
- K082927BIOEMG III2Cleared 510(K)
- K043373DOLOTENS DENTAL TM 12Cleared 510(K)
- K030869BITESTRIP2Cleared 510(K)
- K003176BIOEMG II AND BIOJVA2Cleared 510(K)
- K003287MODEL K7 EVALUATION DEVICE2Cleared 510(K)
- K992694MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I2Cleared 510(K)
- K981563BIOPAK MEASUREMENT SYSTEM2Cleared 510(K)
- K944134K6-1 DIAGNOSTIC SYSTEM VERSION 3.12Cleared 510(K)
- K922456K6-I DIAGNOSTIC SYSTEM2Cleared 510(K)
- K921919MS-100 MYO-SCANNER OR MS-100 EMG SCANNER2Cleared 510(K)
- K873947BIO-EMG MODEL 8002Cleared 510(K)
- K862121E.W.L. P-TENS/H-WAVE2Cleared 510(K)
- K862092COMFORTRON2Cleared 510(K)
- K850425DENTAL ANESTHESIA APPARATUS2Cleared 510(K)
- K830034MODEL EM-2 BIOELECTRIC PROCESSOR2Cleared 510(K)
- K810528MODEL EM-IR2Cleared 510(K)
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical 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
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- 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
E.W.L. P-TENS/H-WAVE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K862121
- 510(k) Type
- Traditional
- Applicant
- ELECTRONIC WAVEFORM LABORATORY, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/17/1987
- Days to Decision
- 379 days