The following data is part of a premarket notification filed by Ge Medical Systems Information Technologies with the FDA for Model 510 Infant Monitor.
| Device ID | K943308 |
| 510k Number | K943308 |
| Device Name: | MODEL 510 INFANT MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Contact | Richard Cehovsky |
| Correspondent | Richard Cehovsky GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES 61 BARNES PARK RD., NORTH Wallingford, CT 06492 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-08 |
| Decision Date | 1995-07-25 |