The following data is part of a premarket notification filed by Thermoquest Corp. with the FDA for Forma Scientific Direct Heat Incubators.
| Device ID | K001524 |
| 510k Number | K001524 |
| Device Name: | FORMA SCIENTIFIC DIRECT HEAT INCUBATORS |
| Classification | Accessory, Assisted Reproduction |
| Applicant | THERMOQUEST CORP. MILL CREEK RD. Marietta, OH 45750 |
| Contact | Richard L Miller |
| Correspondent | Richard L Miller THERMOQUEST CORP. MILL CREEK RD. Marietta, OH 45750 |
| Product Code | MQG |
| CFR Regulation Number | 884.6120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-16 |
| Decision Date | 2000-07-12 |