The following data is part of a premarket notification filed by Ideal Life Inc. with the FDA for Ideal Life Pod (model Ilp 0001).
| Device ID | K080538 |
| 510k Number | K080538 |
| Device Name: | IDEAL LIFE POD (MODEL ILP 0001) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | IDEAL LIFE INC. 2995 STEVEN MARTIN DR Fairfax, VA 22031 |
| Contact | Diane Horwitz |
| Correspondent | Diane Horwitz IDEAL LIFE INC. 2995 STEVEN MARTIN DR Fairfax, VA 22031 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-26 |
| Decision Date | 2008-07-03 |
| Summary: | summary |