The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Percupump Ii With Eda.
| Device ID | K961845 |
| 510k Number | K961845 |
| Device Name: | PERCUPUMP II WITH EDA |
| Classification | Plethysmograph, Impedance |
| Applicant | E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Contact | Peter Aprile |
| Correspondent | Peter Aprile E-Z-EM, INC. 717 MAIN ST. Westbury, NY 11590 |
| Product Code | DSB |
| CFR Regulation Number | 870.2770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-13 |
| Decision Date | 1997-01-23 |