The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for The Karl Storz Hamou Endomat.
| Device ID | K936231 |
| 510k Number | K936231 |
| Device Name: | THE KARL STORZ HAMOU ENDOMAT |
| Classification | Insufflator, Hysteroscopic |
| Applicant | KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Contact | Susie S Chen |
| Correspondent | Susie S Chen KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City, CA 90230 -7600 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1995-01-24 |