510(k) K021439
- Device
- MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO
- Applicant
- ANIMAS CORP.
- 510(k) number
- K021439
- Product code
- LZG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-29
- Date received
- 2002-05-06
- Regulation
- 880.5725
- Classification name
- Pump, Infusion, Insulin
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL J ANDREWS
- Address
- 590 E. Lancaster Ave. Frazer PA US 19355 19355
FDA Registration Numbers#
- 1721676
- 3009515470
- 2032227
- 3007981285
- 3007007790
- 3001058982
- 9617604
- 3007871880
- 3013636348
- 3016540876
- 1313700
- 3012307300
- 9616814
- 3015218509
- 3008810357
- 9610126
- 3010162782
- 3007939342
- 3042027705
- 2029275
- 3005627859
- 3012421607
- 3006194679
- 2246552
- 1220477
- 3008824097
- 3006479639
- 3014585508
- 3002806818
- 3013756811
- 3009337401
- 3007710663
- 3010291427
- 3020976354
- 3010047442
- 3011393376
- 3027453514
- 3005340341
Source Documents#
Other 510(k) Records For Product Code LZG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253534 | Pivot Insulin Delivery System | Modular Medical | 2026-04-08 |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024-09-04 |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | 2024-07-02 |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023-04-24 |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | 2022-04-06 |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | 2021-08-13 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019-10-21 |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019-01-08 |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018-06-01 |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017-04-18 |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | 2016-10-25 |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016-07-25 |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | 2016-07-13 |
| K160252 | OmniPod Insulin Management System | Insulet Corporation | 2016-04-27 |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015-01-09 |
Legacy Summary#
summary
FDA Review#
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