| Primary Device ID | 04961333247417 |
| NIH Device Record Key | 9bfffaa7-1205-4edc-8d2a-d6e89d079703 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) |
| Version Model Number | 6600 |
| Company DUNS | 083211284 |
| Company Name | PENTAX OF AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333247417 [Primary] |
| KLX | Electroglottograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-17 |
| Device Publish Date | 2019-06-07 |
| 04961333255696 - Digital Capture v3.7.0 | 2025-09-22 9380 Digital Capture Software |
| 04961333255979 - MICROPHONE ASSAY KIT | 2025-07-29 6651 MICROPHONE ASSAY KIT(MU0P00000956)(Accessory for PAS 6600) |
| 04961333255986 - Disposables Kit | 2025-07-29 6650 Disposables Kit (MU0P00001081)(Accessory for PAS 6600) |
| 04961333255016 - LARYNGOSTROBOSCOPE | 2025-05-05 LARYNGEAL STROBE 9500 |
| 04961333255702 - LARYNGOSTROBOSCOPE | 2025-05-05 9500LX, Laryngeal Microphone "Accessory for 9500" |
| 04961333255719 - LARYNGOSTROBOSCOPE | 2025-05-05 9500MC, Lapel Microphone "Accessory for 9500" |
| 04961333255726 - LARYNGOSTROBOSCOPE | 2025-05-05 9500FS, Footswitch "Accessory for 9500 " |
| 00854924006255 - C2 CryoBalloon Ablation System | 2025-04-14 Gen 2 360 Degree Pear Catheter |