The following data is part of a premarket notification filed by Laborie Medical Tech Corp. with the FDA for Ano-rectal Manometry Option, Model Number Uds-arm.
| Device ID | K963064 |
| 510k Number | K963064 |
| Device Name: | ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | LABORIE MEDICAL TECH CORP. 6 HURRICANE LANE, #2 Williston, VT 05495 |
| Contact | Thomas Hirte |
| Correspondent | Thomas Hirte LABORIE MEDICAL TECH CORP. 6 HURRICANE LANE, #2 Williston, VT 05495 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1997-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20627825001070 | K963064 | 000 |