Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- OWPBiological Sterilization Process Indicator With Recombinant-Dna Plasmid2Product Code
- LLCContainer, Supplementary NitroglycerinUProduct Code
- LLDPort & Catheter, Implanted, Subcutaneous, IntraperitonealUProduct Code
- LMQDevice, Peritoneal Access, Subcutaneous, Implanted3Product Code
- LNXMedical Computers And SoftwareUProduct Code
- LNYCatheter, Percutaneous, Long Term, Intraspinal3Product Code
- LPZContainer, Frozen Donor Tissue StorageUProduct Code
- LSXController, Closed-Loop, Blood-Pressure3Product Code
- QKYDecontamination Systems For N95 RespiratorsNProduct Code
- LDHSystem, Delivery, Allergen And VaccineUProduct Code
- LKBPad, Alcohol, Device DisinfectantUProduct Code
- LKKPump, Infusion, Implanted, Programmable3Product Code
- LWEBone Marrow Collection/Transfusion Kit2Product Code
- MQTPump, Drug Administration, Closed Loop3Product Code
- NSXSoftware, Transmission And Storage, Patient DataUProduct Code
- PGOAnti-Stick Glass SyringeNProduct Code
- POTLockbox (Export Only)NProduct Code
- PWCGeneral Wellness ProductUProduct Code
- QBPCap, Device DisinfectantUProduct Code
- QIXSystem, Transdermal Delivery, Cder Or Cber LedNProduct Code
- QIYNasal Spray, Systemic Delivery, Cder Or Cber LedNProduct Code
- QIZMaterial, Implantable For Controlled Release, Cder Or Cber LedNProduct Code
- QKRFace Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health EmergencyNProduct Code
- QKUNon-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)NProduct Code
- QLDProtective Barrier EnclosureNProduct Code
- QLEProtective Barrier Enclosure With Negative PressureNProduct Code
- QMFMask, Surgical, Eua AuthorizedNProduct Code
- QOZBarrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health EmergencyNProduct Code
- QJTRigid Sterilization Container With Software2Product Code
- QTGInfant Supine Sleep System2Product Code
- QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant2Product Code
- QWXActive Noise Attenuation System For Infant Incubators2Product Code
- QXJWhole Room Microbial Reduction Device2Product Code
- QZABody Temperature Sensing Software2Product Code
- QPKEua FaceshieldsNProduct Code
- QZTGowns And Other ApparelNProduct Code
- SBEDigital Physical/Chemical Sterilization Process Sensor2Product Code
- QVBBiological Sterilization Indicator With Indirect Growth Detection2Product Code
- QXQRespiratory Accessory Microbial Reduction Device.2Product Code
- SCSUltraviolet Radiation Disinfection Chamber Device2Product Code
- SDCQualitative Cleaning Process Protein Indicator2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- 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
Body Temperature Software (BTS)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN230050
- 510(k) Type
- Direct
- Applicant
- Fitbit LLC
- Country
- United States
- FDA Decision
- Deleted
- Decision Date
- 12/15/2023
- Days to Decision
- 151 days