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- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Serological ReagentsCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- QFGAlternate Controller Enabled Insulin Infusion Pump2Product Code
- K250930twiist system2Cleared 510(K)
- K234027embecta Insulin Delivery System2Cleared 510(K)
- K241078Tandem Mobi Insulin Pump with interoperable technology2Cleared 510(K)
- K241178DEKA ACE Pump System2Cleared 510(K)
- K240309Tandem Mobi insulin pump with interoperable technology2Cleared 510(K)
- K233952DEKA ACE Pump System2Cleared 510(K)
- K230545Inessa System2Cleared 510(K)
- K232380t:slim X2 Insulin Pump with Interoperable Technology2Cleared 510(K)
- K231826Omnipod 5 ACE Pump2Cleared 510(K)
- K233044Tandem Mobi insulin pump with interoperable technology2Cleared 510(K)
- K213134Accu-Chek Solo micropump system with interoperable technology2Cleared 510(K)
- K213536DEKA ACE Pump System2Cleared 510(K)
- K223213Tandem Mobi Insulin Pump with Interoperable Technology2Cleared 510(K)
- K231485iLet® ACE Pump2Cleared 510(K)
- K223846iLet® ACE Pump2Cleared 510(K)
- K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)2Cleared 510(K)
- K203768Omnipod 5 ACE Pump (Pod)2Cleared 510(K)
- K201214t:slim X2 Insulin Pump with Interoperable Technology2Cleared 510(K)
- K191679Omnipod DASH Insulin Management System with interoperable technology2Cleared 510(K)
- DEN180058t:slim X2 insulin pump with interoperable technology2Cleared 510(K)
- LZFPump, Infusion, Analytical Sampling2Product Code
- LZGPump, Infusion, Insulin2Product Code
- Subpart F—Immunological Test SystemsCFR Sub-Part
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iLet® ACE Pump
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K223846
- 510(k) Type
- Traditional
- Applicant
- Beta Bionics, Inc
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/19/2023
- Days to Decision
- 150 days
- Submission Type
- Summary