510(k) K010130
- Device
- POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
- Applicant
- Medtronic Functional Diagnostics A/S
- 510(k) number
- K010130
- Product code
- FFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-02-07
- Date received
- 2001-01-16
- Regulation
- 876.1725
- Classification name
- System, Gastrointestinal Motility (Electrical)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- TOVE KJAER
- Address
- 16-18 Tonsbakken Skovlunde DK DK-2740 DK-2740
FDA Registration Numbers#
- 1123137
- 3010381606
- 3012480535
- 3008717264
- 3015198783
- 8020893
- 3007662958
- 9611668
- 3004904811
- 3009106214
- 3002821211
- 3011790297
- 3035451914
- 3010082909
- 3016544248
- 9611896
- 9710107
- 3018094310
- 3012302888
- 3008361498
- 1836324
- 2023374
- 9681384
- 3016854619
- 3002806603
- 3013973539
- 3008414621
- 3009445917
- 3017448360
- 1126271
- 1119033
Source Documents#
Other 510(k) Records For Product Code FFX#
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| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016-06-20 |
| K160725 | EndoFLIP | Crospon, Ltd. | 2016-05-01 |