The following data is part of a premarket notification filed by Morgan Scientific, Inc. with the FDA for Body Box 5500.
| Device ID | K022636 |
| 510k Number | K022636 |
| Device Name: | BODY BOX 5500 |
| Classification | Plethysmograph, Volume |
| Applicant | MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832 |
| Contact | Patrick F Morgan |
| Correspondent | Patrick F Morgan MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832 |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-08 |
| Decision Date | 2003-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05407003160031 | K022636 | 000 |
| 05407003160024 | K022636 | 000 |
| 05407003160017 | K022636 | 000 |