The following data is part of a premarket notification filed by Hadleigh Health Technologies, Llc with the FDA for Pocket Colposcope System.
| Device ID | K181034 |
| 510k Number | K181034 |
| Device Name: | Pocket Colposcope System |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | Hadleigh Health Technologies, LLC 30 Castro Ave. San Rafael, CA 94901 |
| Contact | Robert Miros |
| Correspondent | Spencer Walker University Of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, UT 84112 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-18 |
| Decision Date | 2018-09-21 |
| Summary: | summary |