The following data is part of a premarket notification filed by Cybermedic, Inc. with the FDA for Neonatal Metascope.
| Device ID | K903959 |
| 510k Number | K903959 |
| Device Name: | NEONATAL METASCOPE |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | CYBERMEDIC, INC. C/O MCKENNA & CUNEO LAW OFFICE 1575 EYE STREET, N.W. Washington, DC 20005 |
| Contact | Richard Manthei |
| Correspondent | Richard Manthei CYBERMEDIC, INC. C/O MCKENNA & CUNEO LAW OFFICE 1575 EYE STREET, N.W. Washington, DC 20005 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-11-23 |