The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Jm-102 Jaundice Meter.
| Device ID | K972309 |
| 510k Number | K972309 |
| Device Name: | JM-102 JAUNDICE METER |
| Classification | Bilirubin (total And Unbound) In The Neonate Test System |
| Applicant | AIR-SHIELDS, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | T. Whit Athey |
| Correspondent | T. Whit Athey AIR-SHIELDS, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | MQM |
| CFR Regulation Number | 862.1113 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1998-09-22 |
| Summary: | summary |