The following data is part of a premarket notification filed by Stratoscientific with the FDA for Steth Io Spot.
| Device ID | K220196 |
| 510k Number | K220196 |
| Device Name: | Steth IO Spot |
| Classification | Stethoscope, Electronic |
| Applicant | StratoScientific 19125 North Creek Pkwy #120 Bothell, WA 98011 |
| Contact | Mahesh Mulumudi |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-01-24 |
| Decision Date | 2022-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860135001958 | K220196 | 000 |