The following data is part of a premarket notification filed by Ajw Technology Consultants, Inc. with the FDA for Amico Ce Series Surgical Lights, Mira Led Series Minor Surgical Lights.
| Device ID | K131893 |
| 510k Number | K131893 |
| Device Name: | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | AJW TECHNOLOGY CONSULTANTS, INC. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Contact | Janet Douglas |
| Correspondent | Janet Douglas AJW TECHNOLOGY CONSULTANTS, INC. 445 APOLLO BEACH BLVD Apollo Beach, FL 33572 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2013-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00667774000249 | K131893 | 000 |
| 00667774000119 | K131893 | 000 |
| 00667774000102 | K131893 | 000 |
| 00667774000096 | K131893 | 000 |
| 00667774000089 | K131893 | 000 |
| 00667774000072 | K131893 | 000 |
| 00667774000065 | K131893 | 000 |
| 00667774000058 | K131893 | 000 |
| 00667774000041 | K131893 | 000 |
| 00667774000034 | K131893 | 000 |
| 00667774000027 | K131893 | 000 |
| 00667774000126 | K131893 | 000 |
| 00667774000133 | K131893 | 000 |
| 00667774000232 | K131893 | 000 |
| 00667774000225 | K131893 | 000 |
| 00667774000218 | K131893 | 000 |
| 00667774000201 | K131893 | 000 |
| 00667774000195 | K131893 | 000 |
| 00667774000188 | K131893 | 000 |
| 00667774000171 | K131893 | 000 |
| 00667774000164 | K131893 | 000 |
| 00667774000157 | K131893 | 000 |
| 00667774000140 | K131893 | 000 |
| 00667774000010 | K131893 | 000 |