SPECTROS MEDICAL DEVICES INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004957206 | 3004957206 | SPECTROS MEDICAL DEVICES INC | 1 | N | 2020-04-25 | 2211 Norfolk St #1110 Houston TX US 77098 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 63304 | 2060326010 | K192322 | T-Stat 2.0 Microvascular Tissue Oximeter | MUD | 2019-09-23 |
| 63304 | 1650809977 | K081233 | T-STAT 303 ISCHEMIA MONITORING SYSTEM | MUD | 2008-07-28 |
| 63304 | 1779924869 | K040684 | T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 | MUD | 2004-11-05 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MUD | 3 | 2019-09-23 |