The following data is part of a premarket notification filed by Kinetic Concepts, Inc. with the FDA for Grand Cooling Machine.
| Device ID | K891152 |
| 510k Number | K891152 |
| Device Name: | GRAND COOLING MACHINE |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Contact | Wehrmeyer, Jr |
| Correspondent | Wehrmeyer, Jr KINETIC CONCEPTS, INC. P.O. BOX 8588 San Antonio, TX 78208 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-03-23 |