The following data is part of a De Novo classification by 3pm Co., Inc. with the FDA for The 3pm Egg Machine.
| DeNovo ID | DEN990005 |
| Device Name: | THE 3PM EGG MACHINE |
| Classification | System, Electrogastrography (egg) |
| Applicant | 3PM CO., INC. 2000 M Street, N.w. 7th Floor Washington, DC 20036 -3307 |
| Contact | Daniel J Manelli |
| Product Code | MYE |
| CFR Regulation Number | 876.1735 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K984637 |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Post-NSE |
| Date Received | 1999-07-12 |
| Decision Date | 1999-08-20 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864359000223 | DEN990005 | 000 |
| 00864359000216 | DEN990005 | 000 |
| 00864359000209 | DEN990005 | 000 |
| 00864359000285 | DEN990005 | 000 |
| 00864359000278 | DEN990005 | 000 |
| 00864359000261 | DEN990005 | 000 |
| 00864359000254 | DEN990005 | 000 |
| 00864359000247 | DEN990005 | 000 |
| 00864359000230 | DEN990005 | 000 |