The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Pcm 2000; Isolair Apr Model 2735.
| Device ID | K970448 |
| 510k Number | K970448 |
| Device Name: | PCM 2000; ISOLAIR APR MODEL 2735 |
| Classification | Respirator, Surgical |
| Applicant | TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Contact | Ruth Jones |
| Correspondent | Ruth Jones TECNOL MEDICAL PRODUCTS, INC. 7201 INDUSTRIAL PARK BLVD. Fort Worth, TX 76180 |
| Product Code | MSH |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-04-30 |
| Summary: | summary |