The following data is part of a premarket notification filed by Ideal Life Inc. with the FDA for Ideal Life Bp-manager, Model Bpm 0001; Ideal Life Pod, Model Ilp 0001.
| Device ID | K060504 |
| 510k Number | K060504 |
| Device Name: | IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | IDEAL LIFE INC. 1220 19TH STREET N.W. SUITE 300 Washington, DC 20036 |
| Contact | Diane Mandell |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-02-27 |
| Decision Date | 2006-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00804084000112 | K060504 | 000 |
| 10804084000010 | K060504 | 000 |