The following data is part of a premarket notification filed by Mark Solutions, Inc. with the FDA for Mtb 1043 Treatment Booth.
| Device ID | K944133 |
| 510k Number | K944133 |
| Device Name: | MTB 1043 TREATMENT BOOTH |
| Classification | Chamber, Patient Isolation |
| Applicant | MARK SOLUTIONS, INC. 87 ROUTE 17 NORTH Maywood, NJ 07607 |
| Contact | Joseph L Ferraro |
| Correspondent | Joseph L Ferraro MARK SOLUTIONS, INC. 87 ROUTE 17 NORTH Maywood, NJ 07607 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-24 |
| Decision Date | 1995-09-07 |